Course Descriptions

QA/RA Course Descriptions

All courses are three semester hours.

5000. Special Topics – QA/RA
Special topics in QA/RA (described in further detail in the schedule of classes).

5401. Fundamentals of Pharmacology and Pharmacokinetics
This introductory course to general pharmacology includes discussions of the mechanisms of action of selected drug classes. It covers pharmacokinetics, including clearance, bioavailability, compartment models, extravascular dosing, nonlinear pharmacokinetics and pharmacodynamics as they apply to the drug development process. 
Formerly Pharmaceutics 400. Not open to students who have taken Pharmaceutics 400 or Pharmaceutics 405.

5408. Pharmacoeconomics
The economic methodologies used to evaluate the cost effectiveness of drug therapy are reviewed. Cost effectiveness is examined in terms of outcome assessment and quality of life measurements. The course explores the dynamic environment of health care and the process of drug product selection in managed care.
Formerly Pharmaceutics 480. Not open to students who have taken Pharmaceutics 480.

5451. Statistical Quality Control
An introduction to statistical concepts, this course reviews control charts for variables, probability theory, control charts for attributes, and acceptance sampling systems.  Class discussions include application to quality control of pharmaceutical manufacturing. Formerly Pharmaceutics 451.  Not open to students who have taken Pharmaceutics 451.

5452. Acceptance Sampling
This course covers the statistical basis of acceptance sampling plans and schemes and pharmacopoeial tests used in the pharmaceutical industry in evaluating incoming raw materials, package components and closures, in-process materials, and finished products. Proper use of these plans and the degree of certainty they provide for the accept/reject decision will be emphasized.
Formerly Pharmaceutics 452. Not open to students who have taken Pharmaceutics 452.

5458. The Global Biopharmaceutical Industry (including the Waxman-Hatch Act)
Prerequisite:  Drug Development (Pharmaceutics 5459)
What social and economic factors contributed to the development of innovator and generic pharmaceutical companies, and what are their current and future trends? This course introduces students to the basic structure of the pharmaceutical industry, examining the growth and relationships among various sectors, including the fully-integrated companies of big pharma, the generic and biotech industry, and specialty and service companies, such as CROs and CMOs. Social, political, demographic, economic, and technological influences will be examined not only in the US domestic market, but also across major world economies, including the differences between national health and single-payer systems. A segment of the course focuses on the impact of the Waxman-Hatch Act on drug price competition and patent term restoration.   

5459. Drug Development
This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governing the process, including the interactions with FDA, ICH, and other regulatory agencies. 
Note: this course is required for the MS in QA/RA, the Drug Development Certificate, the Certificate in Clinical Trial Management, the Certificate in Biopharmaceuticals and Generic Drugs, and the Basic Pharmaceutical Development Certificate.
Formerly Pharmaceutics 459. Not open to students who have taken Pharmaceutics 459.

5469. Pharmaceutical Laboratory Quality Systems and Operations
The laboratory plays a key role in the manufacture and release of pharmaceuticals. An effective QC lab assures the integrity of the data generated to enable the release of raw materials, in-process, and finished products and also meets production schedules. In addition, production-related responsibilities must meet with compliance standards. This course covers these responsibilities in detail while providing insight on how to meet internal and regulatory requirements for lab operations. Why labs fail and what actions must be taken to prevent failure are covered in depth.
Formerly Pharmaceutics 489. Not open to students who have taken Pharmaceutics 489.

5471. Biotechnology: Bioprocess Basics
Prerequisite:  Undergraduate introductory Biochemistry and Chemistry courses.
This course covers the major steps of the biotechnology process: preparation of media, fermentation, recovery, chromatography, and related purification processes. Consideration is given to their regulatory and control aspects. Included is an introduction to basic biosciences (e.g., microbiology, biochemistry, and genetic engineering).
Formerly Pharmaceutics 481. Not open to students who have taken Pharmaceutics 481. Also not open to Non-Thesis MS students who have taken or Pharmaceutics 475 or 5471 in the Non-Thesis MS program.

5472. Pharmaceutical Marketing
This course describes the marketing dynamics of the healthcare industry and the ways in which pharmaceutical companies can better meet the changing needs of patients and managed care. Focusing on individual marketing techniques, it stresses the development of multidisciplinary marketing teams. The product attributes discussed in the selling process are efficacy, safety, cost effectiveness, compliance, and treatment outcomes.
Formerly Pharmaceutics 482. Not open to students who have taken Pharmaceutics 482.

5473. Generic Drug Regulation (ANDAs)
Prerequisite: Drug Development (Pharmaceutics 5459).
When marketing exclusivity or the patent for a drug product expires, or the courts rule that the patent is not valid, other manufacturers can gain approval to market and sell a similar product. The manufacturers of these generic forms may obtain FDA approval based on an Abbreviated New Drug Application (ANDA), which documents the bioequivalence of their product to the pioneer brand product.  This course reviews specific case studies of generic drug product approvals using ANDA regulations and court decisions. It provides an understanding of the current regulatory environment for generic drugs and introduces students to the problems and situations that are unique to this industry.  A review of  generic product categories (authorized generics, generic biopharmaceuticals, generic vaccines) includes the different approaches used to develop generic products, explaining terms such as a Paragraph IV filing.  After discussing the interaction between generic drug companies and the FDA, foreign market regulations for generic drugs will be studied, covering global generic markets in Europe, Asia, South America, and other selected jurisdictions. Post-marketing regulation and pharmacovigilance will also be included. Formerly Pharmaceutics 483.  Not open to students who have taken Pharmaceutics 483.

5474. Process Validation
Prerequisites: BS in Pharmacy, Chemistry, Biology or Engineering and strong science background, including familiarity with chemistry, biology, and physics. Students should also have a basic understanding of pharmaceutical manufacturing processes.
Since the concept of “validation” originally appeared in GMP regulations, it has extended to every step in product manufacturing from building the plant to the methods used for testing and releasing its products. The course exposes students to all aspects of validation. FDA Guides and Guidelines, as well as the current emphasis on validation concerns by FDA (as identified in 483 and Warning Letter observations), will be incorporated. Students develop acceptable validation protocols and learn what constitutes an acceptable validation report.
Formerly Pharmaceutics 484. Not open to students who have taken Pharmaceutics 484.

5476. Good Laboratory Practices
This course explores the regulatory and quality assurance issues pertinent to pre-clinical safety research. Research study design and processes will be analyzed by pharmacologic and toxicologic methods and for carcinogenicity and reproductive toxicology. Some time is devoted to mutagenicity and pharmacokinetics, discussed in the context of developing a safety profile and determining the potential risk to humans in subsequent clinical trials.
Note: this course fulfills the GXP requirement for QA/RA MS students and for the Drug Development Certificate.
Formerly Pharmaceutics 486. Not open to students who have taken Pharmaceutics 486.

5477. Good Manufacturing Practices
This course provides an introduction to cGMPs (current good manufacturing practices). Regulations for drugs under the Food, Drug and Cosmetic Act (21 CFR 210 and 211) and their implication for personnel, buildings, equipment, and records will be thoroughly reviewed and studied. It includes a study of pertinent legal decisions and regulatory actions based on non-compliance. 
Notes: this course fulfills the GXP requirement for QA/RA MS students and for the Drug Development Certificate.
Students with extensive manufacturing experience in GMPs may petition the School to allow them to replace the basic GMP class with Advanced GMPs. To do so, students must have at least five years of GMP experience and submit a resume to the QA/RA Office for final approval. 
Formerly Pharmaceutics 487. Not open to students who have taken Pharmaceutics 487.

5478. High Purity Water Systems
Prerequisite:  college-level chemistry course.
This course examines high purity water systems from a Quality Function perspective, covering basic aspects of system design and operation. Special attention is paid to unit operations, sanitization procedures, and routine monitoring programs. Students learn to plan validations and establish routine monitoring programs to assess ongoing quality. Domestic (NFDWR/NSDWR) requirements and international standards and regulatory expectations are discussed.
Formerly Pharmaceutics 488. Not open to students who have taken Pharmaceutics 488.

5479. Advanced Good Manufacturing Practices – Defining “c”
Prerequisite: successful completion of Pharmaceutics 5477 or permission of the instructor.
This course brings students from the basic GMP concepts presented in Pharmaceutics 5477 to a fuller understanding of the concepts of current good manufacturing practices. Discussions include how to evaluate FDA 483s and Warning Letters, the routine review of periodicals, including the Pink Sheet, Gold Sheet, and other GMP-oriented documents, and how to evaluate information provided by the FDA. Recalls are discussed.
Formerly Pharmaceutics 479. Not open to students who have taken Pharmaceutics 479.

5491. Pre-Approval Inspections
Prerequisites:  Drug Development (Pharmaceutics 5459) and Good Manufacturing Practices (Pharmaceutics 5477).
This course provides a detailed overview of Pre-Approval Inspections and how to conduct audits of facilities based on the responsibilities delineated in a pending drug application, including NDAs, ANDAs and NADAs. Emphasis is placed on reviewing the Pre-approval audit process, Pre-Approval laboratory issues (including analytical and microbiological), technology transfer, case studies involving various dosage forms, and outsourcing issues. This course stresses key areas for Pre-Approval inspection audits. Case studies help prepare students for issues arising during a Pre-Approval inspection. The history and evolution of the Pre-Approval program are discussed.
Formerly Pharmaceutics 490. Not open to students who have taken Pharmaceutics 490.

5492. Production of Sterile Parenterals
This course reviews the theory and practice involved in the preparation of sterile, injectable products, covering formulation, manufacturing, facility requirements, validation and regulatory issues. Upon completion of the course, students will develop an understanding of the routes of administration of injectable drugs and the types of injections, current formulation methods, aseptic manufacturing processes, requirements for sterile manufacturing facilities, and validation, compliance and regulatory issues.
Formerly Pharmaceutics 492. Not open to students who have taken Pharmaceutics 492.

5493. Sterilization Processes: Manufacturing
This course surveys sterilization processes used in the pharmaceutical, medical device, in-vitro diagnostic, and biotech industries. Current methods of sterilization are discussed, including thermal, gaseous, radiation, filtration, and aseptic processing. Students learn basic aspects of sterilization science as well as design, review, and audit sterilization validations and processes according to industry practices.
Formerly Pharmaceutics 493. Not open to students who have taken Pharmaceutics 493.

5494. Quality Audit
Prerequisite: A Good Practices course (Pharmaceutics 5476 or 5477 or 5479 or 5536)
This course covers topics in quality assurance principles, audit techniques, audit types, audit presentation and reports, auditing procedures for GMPs, GCPs, and GLPs. Note: this course is required for the MS in QA/RA; however, students interested in RA may substitute IND/NDA Submissions.
Formerly Pharmaceutics 494. Not open to students who have taken Pharmaceutics 494.

5495. IND/NDA Submissions
Prerequisite: Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592). 
This course covers the development of IND and NDA submissions for FDA review. The major emphasis is directed toward developing an understanding of the philosophies and requirements FDA imposes on data submitted to support INDs and NDAs. It covers the process of producing INDs and NDAs (managing the teams, producing the submission, using electronic media) and emphasizes how to work with FDA to gain approval of a submission. FDA meetings, advisory panel hearings, appeals, strategies for review and approval of NDAs, use of Orphan drug status, and the various avenues for expedited review are discussed.
Note: This course is required for the MS in QA/RA: however, students interested in QA may substitute Quality Audit.
Formerly Pharmaceutics 495. Not open to students who have taken Pharmaceutics 495.

5496. Regulation of Medical Devices: Compliance
This course examines the broad scope of the medical device industry and its quality assurance practices, covering the preclinical, clinical, manufacturing, postmarket reporting, and device-tracking compliance regulations in the U.S. and other major world markets. Formerly Pharmaceutics 496.  Not open to students who have taken Pharmaceutics 496.

5497. Statistics for Clinical Trials
Assuming no previous courses in statistics, this introductory course reviews topics of interest in statistical evaluation of clinical trials. 
Formerly Pharmaceutics 497. Not open to students who have taken Pharmaceutics 497.

5498. Computer Validation
This course focuses on the application of computer validation concepts to computer systems operating within a pharmaceutical research and development environment. It presents the specific needs and responsibilities of the various regulatory requirements and guidelines (both domestic and global).
Formerly Pharmaceutics 498. Not open to students who have taken Pharmaceutics 498.

5499. Drug Dosage Forms
Prerequisite: strong science background.
Through an overview of drug dosage form design and manufacturing technology, principles of pharmaceutical processing and pharmaceutical dosage form design (including preformulation and biopharmaceutics) are discussed, including dosage forms such as tablets, capsules, modified dosage forms, semi-solid products, and transdermal delivery systems.
Formerly Pharmaceutics 499. Not open to students who have taken Pharmaceutics 499.

5502. Regulation of Medical Devices: Submissions
This course provides an overview of medical device submissions. The course begins with a review of laws specific to medical devices such as the requirement for pre-market submissions. Specific topics include device classification, investigational device exemption (IDE) applications, pre-market notification submissions [510(k)s], pre-market approval applications (PMAs), humanitarian device exemptions (HDEs), product development protocols (PDPs), STED and an overview of Global Harmonization Task Force recommendations. 
Formerly Pharmaceutics 500. Not open to students who have taken Pharmaceutics 500.

5505. Global Medical Device Regulation
This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements (including both voluntary and mandatory standards and directives and progressing to in-depth analyses of market specific requirements), the course provides students with resources to meet the regulatory requirements for the largest world markets. The Medical Device Directive, the In Vitro Diagnostic Directive and the Active Implantable Medical Device Directive will be discussed, as well as initiatives by the Global Harmonization Task Force related to the classification, development, and complaint handling for medical devices. As part of this course, the student will learn the quality system requirements of ISO13485, risk management according to ISO14971, and how to CE mark their product. Country-specific regulatory requirements for Canada, EU, Australia and Japan are included. Formerly Pharmaceutics 505.  Not open to students who have taken Pharmaceutics 505.

5506. Environmental Law and Regulation (EPA)
This course explores the regulatory arena of the agricultural and chemical industries. Students gain a basic knowledge of environmental laws and the key federal agencies (e.g., EPA, NRC, USFWS) influencing the chemical industry. Building upon QA/RA skills, students interpret and understand the development, registration, and manufacturing of EPA-related products such as pesticides. They acquire a deeper appreciation of the global impact of pesticide regulation and examine registration requirements for international quality assurance (e.g., EU/OECD, MJAFF). Discussions of many well-publicized controversies such as Proposition 65 in California, Rachel Carson’s Silent Spring, federal ground water regulation, and the use of hormones in animal food are included, in addition to a field trip.
Formerly Pharmaceutics 510. Not open to students who have taken Pharmaceutics 510.

5507.  Regulation of Non-Prescription Healthcare Products
Starting by reviewing the history of non-prescription products in the US, this course will focus on their past and present regulation, including the US FDA OTC Montograph system., non-prescription NDA products, and RX to OTC switches.  It will also examine “behind the Counter” drugs and include an overview of non-Rx drugs in Australia, New Zealand, Canada, the EU, and ASEAN markets.  Discussions of cosmetics and nutraceuticals will be included.

5508. Good Pharmacovigilance Operations
This course provides a solid foundation for understanding/managing the complexities of the lifecycle of an individual case safety report (ICSR). It reviews the process from receipt of the ICSR to reporting to regulatory authorities (both as an expedited ICSR and within a periodic safety update report). It compares US and EU regulations and ICH guidances in this area. It also covers the requirements for a validated safety database to process ICSR and Quality Systems in a Pv department. The course discusses the management of a Pv department and the business decisions required to manage the volume of cases received. Also discussed is the role of Pv agreements and preparation for a Pv inspection.

5511. Advanced Audit Workshop of Quality Systems
Prerequisite: Pharmaceutics 5494 and a Good Practices course (either 5477, 5479, 5486, or 5536) or permission of instructor.
A continuation of Pharmaceutics 5494 (Quality Audit), this course discusses the components of a quality system in greater depth and detail, including control systems, procedures, and documentation. Students design and audit a quality system; they also audit and critique quality systems presented by the faculty member.
Formerly Pharmaceutics 511. Not open to students who have taken Pharmaceutics 511.

5512. Microbiological Concepts in Pharmaceutical Manufacturing
This course addresses essential microbiology concepts of manufacturing and quality control that form the basis of Good Manufacturing Practices for both sterile and non-sterile pharmaceuticals. Emphasis is placed on a review of the following from a microbiological perspective: manufacturing technologies and techniques, building quality into processes, influence of raw material quality on finished product, the meaning of the qualification and validation studies conducted by drug firms, and key microbiological tests performed at in-process and finished product stages. The course stresses practical matters and includes case studies to prepare students for daily issues arising in industry.
Formerly Pharmaceutics 512. Not open to students who have taken Pharmaceutics 512.

5513.  Active Pharmaceutical Ingredients (APIs)
Prerequisite: Drug Development (Pharmaceutics 5459) or a working knowledge of the Chemistry, Manufacturing & Controls (CMCs) in the pharmaceutical industry. Forward resume to QA/RA Office for approval.          
This course will provide a working background on active pharmaceutical ingredients as used in  pharmaceutical dosage forms with areas of focus on the development, manufacturing and global regulations that impact successful marketing approval of products.  The course will primarily focus on small molecule synthetic API’s with biologics being out of scope.

5515. Biologics/Biosimilars: A Regulatory Overview
Prerequisites: Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592). Students are expected to have a strong science background, including familiarity with undergraduate chemistry and biology.
Since the first biopharmaceutical product approval in 1982 (recombinant human insulin), the biotechnology derived product market has been rapidly growing with introduction of a number of promising advances in medicine such as therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. As with traditional drugs (small molecules), the regulatory framework for approval of a biotechnology derived product (biologics) is complicated. In addition, there has been much debate about the introduction of biosimilars using an abbreviated approval process. An overall biologics-based process map beginning with pre-clinical through the post-marketing stage will be discussed. Topics such as therapeutic proteins/peptides, gene therapy, stem cells, vaccines, interference RNAs, PK-PD, world-wide regulatory filings, pre-clinical IND-enabling studies, BLA/CTD filing, biosimilars/follow-on-biologics, selected case studies, immunogenicity, comparability studies, manufacturing challenges, clinical trials, market exclusivity, and related regulatory guidelines will be discussed.

5516. Cleaning Validation
This course will review the different aspects of a pharmaceutical cleaning validation program and the criteria for each.  The course will go from protocol to final report with emphasis on the regulatory risks and consequences.  FDA and other regulatory agency observations will be highlighted to reinforce class material.

5518.  Regulatory Issues in Pharmacogenomics
Pharmacogenetics (PGt) is the study of genetic causes of variability in drug metabolism (pharmacokinetics) and responses to drugs, including adverse events (AEs) and desired pharmacological effects (pharmacodynamics).  Variability can be attributed to variations in DNA, such as polymorphisms, or sequences that influence an enzyme or a receptor activity. Pharmacogenomics (PGx) is the science involving pharmacology and genomics which studies how genetic differences within a population affect body's response to a drug.  After the completion of the Human Genome Project, PGx has become an attractive tool in the attempt to develop personalized medicine that can be adapted to each person's own genetic makeup and lead to a higher therapeutic efficacy.  The FDA (and other regulatory agencies) is requesting that sponsors conducting such programs consider providing pharmacogenomic data to the Agency voluntarily, when such data are not otherwise required under the regulations.  Such voluntary submissions would facilitate the drug approval process and help identify patients who need dose adjustments or are prone to certain toxic effects (reflected in the drug's label). 

5532.  Global Labeling Regulation:  Principles and Practices
Suggested prerequisite:  Drug Development (Pharmaceutics 5459)
This course provides a detailed analysis of corporate labeling practices in the United States and European Union (EU).  It compares and contrasts FDA regulations with more recent EU and International Congress on Harmonization (ICH) regulations, including the impact on corporate labeling documents.  A significant portion of the course will be devoted to new guidelines from FDA and the pharmacovigilance guidelines for the EU market and ICH.

5533. Requirements for Product Labeling and Advertising
Prerequisite: Food and Drug Law I (Pharmaceutics 5592) or permission of the instructor.
This course examines strategies for creating drug labeling during new product development, for updating existing product labeling, and for creating “harmonized” core data sheets for products marketed globally. Students gain insight and awareness of current trends in advertising and promotional regulation.
Formerly Pharmaceutics 533. Not open to students who have taken Pharmaceutics 533.

5534. Regulatory Aspects of Biomedical/Technical Communication
Prerequisite: Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592) or permission of the instructor. 
This course reviews regulatory requirements of biomedical/technical writing in the pharmaceutical industry. Students research, summarize, and organize typical scientific data. Issues of content (relevancy, accuracy, balance, and currency), organization, and style (e.g., American Medical Association Manual of Style and current FDA and ICH guidelines) are addressed. Writing exercises include topics such as the Physician’s Desk Reference, developing product label package inserts, and summarizing studies in pharmacokinetics, pharmacodynamics, efficacy and safety, product development, and stability.
Formerly Pharmaceutics 534. Not open to students who have taken Pharmaceutics 534.

5535. Advanced Topics in Labeling Development
Prerequisite: Requirements for Product Labeling and Advertising (Pharmaceutics 5533) or permission of the instructor.
This course reviews the regulatory and legal fundamentals of labeling FDA-regulated products, specifically, prescription pharmaceuticals, emphasizing the direct application of the regulations to actual practice. It analyzes case studies and current practices, providing an overview of legal, regulatory, and marketing concepts affecting labeling. It discusses the application of current knowledge and explores new trends in the legal and regulatory framework surrounding the development and implementation of drug labeling. As a class project, students are assigned to drug development teams (Regulatory Affairs, Marketing and Clinical) and provided with the known data of their compounds. Teams determine what information is needed to complete the draft labeling for NDA submission, and develop a final label; they hold mock negotiations (internal and with the Agency) and propose changes to labeling in response to post-marketing surveillance.
Formerly Pharmaceutics 535. Not open to students who have taken Pharmaceutics 535.

5536. Good Clinical Practices
This course examines the federal regulatory requirements and processes necessary to conduct valid drug trials on human volunteers. Emphasis is placed on managing the clinical drug study and auditing its processes and generated data. The course also addresses ethical issues and volunteer informed consent. Note: this course fulfills the GXP requirement for QA/RA MS students and for the Drug Development Certificate. It is required for the Certificate in Clinical Trial Management.
Formerly Pharmaceutics 536. Not open to students who have taken Pharmaceutics 536.

5537. Clinical Trial Management
Prerequisite: Good Clinical Practices (Pharmaceutics 5536) or permission of the instructor.
This course is designed to help the clinical research department member and those familiar with the industry working in related fields become more effective members of the clinical research team, whether at a company or an investigator's office. This course covers the day-to-day operations of a clinical trial, from site and investigator selection through monitoring and data retrieval. It covers key topics such as budgeting, protocol preparation, site and investigator selection, monitoring, document and file creation and maintenance, and the participation of key members of the principal investigator's team.
Note: this course is required for the Certificate in Clinical Trial Management.
Formerly Pharmaceutics 537. Not open to students who have taken Pharmaceutics 537.

5538. Clinical Drug Safety and Pharmacovigilance (Formerly called Clinical Safety and Risk Management)
Prerequisite: Drug Development (Pharmaceutics 5459).
This course provides students with an in-depth understanding of what pre-marketing Clinical Safety and Risk Management (CSRM) means in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. Beginning with an historical overview of IND and international safety requirements, it examines the processes and systems in place to support compliance and the strategic documentation required for applications. It also looks at the role of risk management and epidemiological methods used to identify the signals used to quantify, assess, and communicate adverse drug reactions (ADR). Topics include clinical trial policy, the roles of the investigator, patient, and IRBs, privacy issues, informed consent, DSMB, and other related matters.
Note: this course may be substituted in place of Clinical Data Management in the Certificate in Clinical Trial Management.
Formerly Pharmaceutics 538. Not open to students who have taken Pharmaceutics 538.

5539. Global Clinical Drug Development
Prerequisites: two of the following: Drug Development (Pharmaceutics 5459) or Good Clinical Practices (Pharmaceutics 5536) or Food and Drug Law I (Pharmaceutics 5592) or Global Regulatory Affairs (Pharmaceutics 5591).
This course focuses on the specific regulatory requirements of clinical development in the European Union, Eastern Europe, Latin America, Canada, India, China and Japan. It will review the efforts of the International Conference on Harmonization (ICH) to unify Good Clinical Practices (GCPs) in these global areas, exploring the differences between cultures, races, and societies and the impact of socialized medicine. Upon successful completion of this course, students will: gain an overview of multinational clinical drug development; gain a basic understanding of cultural differences towards GCPs in various regions of the world; understand key regulatory bodies and concepts governing clinical development in various global markets; and become familiar with the ICH and its legal requirements for global clinical development.
Note: this class may be substituted in place of Clinical Trial Management in the CTM certificate.
Formerly Pharmaceutics 539. Not open to students who have taken Pharmaceutics 539.

5541. Pharmaceutical Packaging:  Technology and Regulation
This course focuses on the complexities of packaging for the pharmaceutical industry, covering commonly used packaging systems (bottle/blister packaging for Oral solids) as well as niche applications (such as sterile/parenteral, inhalation, and nasal systems).  In addition to the container/closure systems, some of the packaging processing methods will be covered.  A review of the applicable regulatory environment and the submission requirements for drug products will be included.  The submission needs will be covered, with a focus on the needs of the newly implemented Common Technical Document (CTD).  A visit to a manufacturing facility of one of the industry’s suppliers is required. Formerly Pharmaceutics 540.  Not open to students who have taken Pharmaceutics 540.

5542. Regulation of Training: Compliance
This course examines the broad scope of training requirements in the pharmaceutical industry, focusing on compliance issues with regulations governing US and other major world markets in the pre-clinical, clinical, manufacturing, and post-market arenas. After examining the specific regulations governing pharmaceutical industry training, students will learn to evaluate the components of successful industry training formats by acquiring a basic understanding of the statistical techniques used to evaluate its success. During the course, students will develop and implement a mock training program for a specific segment of the industry (GLP, GMP or GCP).
Formerly Pharmaceutics 543. Not open to students who have taken Pharmaceutics 543.

5543. Good Distribution Practices (GDPs) 
Students will study the organizational, managerial and technology issues related to the supply chain, logistics, and distribution functions of the pharmaceutical industry, particularly generic pharmaceuticals.  They will be introduced to the tools and technologies that companies use to optimize their supply chain, logistics, and distribution functions, with specific emphasis on how generic companies configure and operate these aspects.  Topics include anticipatory and response-based systems; postponement; technology; cash flow effects; lean logistics; warehousing; inventory flow and carrying cost s; information flow; customer delivery and service expectations; service reliability; supply chain integration with distributors, drug wholesalers and other channel members;
managing demand timing and uncertainty; transportation, and regulatory and compliance considerations.

5544. Regulatory Intelligence
Prerequisites:  Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592).
This course examines the fundamentals of global regulatory intelligence, including defining what it is, how it is gathered, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product. Students will learn to monitor the legislative and regulatory landscape by assessing various types of accessible information and data. Class discussion and hands-on exercises will provide insights on the collection, analysis, and management of regulatory intelligence. The class will focus on drugs but will also look at other therapeutic products.

5545. Post Approval Changes (PAC)
This course reviews PAC guidelines developed by CDER to maintain product safety, efficacy, and quality while giving manufacturers substantial regulatory relief and flexibility.  A basic review of formulation development of various dosage forms provides a complete understanding of the guidelines and of regulatory strategies for formulation development. Formerly Pharmaceutics 545 (Scale-Up and Post Approval Changes).  Not open to students who have taken Pharmaceutics 545.

5546. Global Pharmaceutical Excipient Regulation
An integral part of almost all pharmaceutical dosage forms, excipients play an important role in drug development. This course discusses the function of excipients, providing an in-depth examination of their unique yet globally diverse regulatory requirements in major world markets. Excipient selection, assessment, and supplier qualifications will be discussed, as well as Adverse Events (AEs) related to excipient quality. This course stresses how global pharmaceutical excipient regulation is critical in developing formulations that have the potential for international approvals.
Formerly Pharmaceutics 546. Not open to students who have taken Pharmaceutics 546.

5547.  Clinical Trial Project Management
This course focuses on ways to lead, manage and operate clinical trials, starting with the development of a clinical development plan through the completion of supporting clinical studies. Designed to familiarize the clinical research professional and those in related fields with predictable planning practices, the course helps students learn to be effective members of a clinical research team. The material covered will be a mix of basic project management methodology, drug development best practices, and the “soft skills” needed to successfully lead and manage a clinical trial team.  Much of the time will be allocated for hands-on application of the topics. Material covers a review of clinical development planning and the design of an appropriate clinical study. The course also discusses the efficient initiation, planning, execution, monitoring/controlling, and closing of a study. Working on teams throughout the course, students develop a Clinical Plan, both in and outside of class, that will be presented at the end of the semester. 

5571. Post-Marketing Safety Surveillance
This course provides an in-depth understanding of post-marketing safety surveillance (PMSS) in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. It begins with a historical overview of PMSS and then reviews the role of epidemiological methods in identifying signals and quantifying, assessing, and preventing adverse drug reactions (ADR). Medical/legal issues, benefits and limitations of safety surveillance systems, labeling changes, the ability to refute false signals, and social and ethical obligations inherent in the conduct of PMSS are discussed.
Formerly Pharmaceutics 571. Not open to students who have taken Pharmaceutics 571.

5572. Vaccines:  QA/RA Issues
Suggested prerequisite:  Drug Development (Pharmaceutics 5459).
This course addresses the history, research and development, manufacture, marketing, and medical impact of vaccines.  Various public policy, regulatory, ethical, and legal issues in this area are discussed as they pertain to the U.S. and, to some extent, international markets.  Beginning with the eradication of smallpox, this course covers the development of widely used vaccines against once common diseases (e.g., polio, mumps, varicella, etc.), to the development of vaccines against HIV, anthrax , and certain types of cancer. Formerly Pharmaceutics 572.  Not open to students who have taken Pharmaceutics 572.

5573. Pharmacoepidemiology
This course introduces students to principles of study design, concepts of causal inference, and major types of epidemiological studies. These principles are applied to the distribution and determination of the effects (expected and unintended, beneficial and adverse) of pharmaceuticals on human populations. Risk-benefit analyses, cost-benefit assessments, regulatory issues, and legal and public health concerns are discussed.
Formerly Pharmaceutics 570. Not open to students who have taken Pharmaceutics 570.

5574.  Pharmaceutical Quality Management Systems
Prerequisites  Drug Development (Pharmaceutics 5459)
This course provides a detailed overview of Pharmaceutical Quality Management Systems through evaluating federal regulations and guidelines.  Emphasis is placed on the development and management of total Quality Systems that meet regulatory expectations.  Topics covered include the development, management, usage and maintenance of Standard Operating Procedures (SOPs), Deviation/Non-conformance Systems, Corrective and Preventative Action Systems, Supplier Management Systems, Change Management Systems, Validation, and Process controls via Key Performance Indicators. Focus is placed on the key areas for inspection readiness and robust Quality Systems development. Current guidelines in Pharmaceutical Quality Systems, including Q10, are evaluated.  This course presents a total Quality Management Systems approach to the pharmaceutical industry, including traditional pharma (small molecule), biologics, and medical devices.

5575. Regulatory Sciences: Managing the Guidelines for Quality
Prerequisite: strong science background required. Fax resume to QA/RA Office for approval.
The International Conference on Harmonization (ICH) has revolutionized the format and content of global regulatory filings with the Common Technical Document (CTD) serving as the platform for this format change. Module 3 of the CTD is also known as the Quality Section and pertains to information related to Chemistry, Manufacturing and Control. ICH Quality Guidelines significantly influence the content of this Module. Recent FDA draft guidelines have incorporated and expanded upon concepts described by the ICH. As the term ‘guideline’ implies, such documents should not be generally viewed as regulations, but as ‘recommendations’ to consider when developing the body of scientific information that ensures a thorough scientific understanding and control of product attributes. Proper interpretation of the guidelines based on sound scientific principles is essential to optimize both the quality and quantity of information submitted to global regulatory agencies. Consequently, review of various ICH and FDA Quality guidelines will be supplemented by a discussion of the basic scientific principles that may influence implementation. This course is designed to focus exclusively on guidelines associated with the development of small molecules from Phase 1 through Phase 4 and will not address issues related to biotechnology. After completing this course students should understand the basic expectations set forth in various ICH and FDA Quality Guidelines. They should also realize that the guidelines are subject to interpretation and not definitive regulations. Regulatory agencies are increasingly willing to engage in dialogue when filings are justified by data and clear scientific rationale presented. 
Formerly Pharmaceutics 580. Not open to students who have taken Pharmaceutics 580.

5576. Global CMC Issues and Regulatory Dossiers
The course provides students with an in-depth knowledge of the major chemistry, manufacturing. and controls (CMC) issues facing the global pharmaceutical industry. Students learn the practical and theoretical skills necessary to develop successful CMC dossiers from the initial clinical application through marketing and post-marketing support. The class emphasizes long range CMC planning to combine technical and regulatory knowledge with strategic thinking. The class is designed for regulatory professionals, managers, and scientists with significant responsibility for CMC dossiers.
Formerly Pharmaceutics 586. Not open to students who have taken Pharmaceutics 586.

5577. CMCs - Biologics
This course provides students with an introduction to the chemistry, manufacturing and controls (CMC) topics involved in the development and licensure of biologic products (biopharmaceuticals, vaccines) in the US, Europe and other highly regulated regions.  Topics will be discussed from the perspective of Regulatory and QA requirements and expectations.  Basic microbiology, cell biology and chemistry concepts will be reviewed with an emphasis on their practical application to product development and RA/QA.  The class is designed to orient RA/QA professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers to the CMC content matter and technical issues that must be addressed in biologic product development and registration.  Topics will include adventitious agents testing, cell and seed bank testing methods and requirements, drug substance production via cell culture, protein and virus purification methods, control and analysis of process impurities, analytical methods and potency testing for characterization and release, strategy for specification setting for release and stability, comparability studies for biologics.  

5578.  Benefit-Risk Management and Safety Signaling of Healthcare Products
This course provides a basic understanding of the principles involved in developing, negotiating, and implementing Benefit-Risk Management Plans.  While the focus will be on the EU and US, the general principles are applicable across multiple jurisdictions.  Starting with the background needed to develop effective benefit-risk management programs, the course will provide an overview of the many factors contributing to the development of such programs.  The sources and methods of  interpretation of data as part of a benefit-risk management strategy will be included.  Importantly, students will acquire practice in developing sections of benefit-risk management programs, enabling them to acquire the skills necessary in evaluating the utility and reliability of such programs

5579. Regulatory and Legal Basis of Pharmacovigilance
Suggested prerequisite: One course in Pharmacovigilance: Post Marketing Safety Surveillance (Pharmaceutics 5571) or Clinical Drug Safety and Pharmcovigilance (Pharmaceutics 5538) or Good Pharmacovigilance Operations (Pharmaceutics 5508)or Benefit Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578).
This course provides students with a basic understanding of the key regulations and laws that influence the development and management of a pharmacovigilance system, either in a manufacturer or health agency environments. The main emphasis will be on FDA, EU, and Japan and ICH, but discussions of emerging countries’ systems will also be included. In addition to pharmaceuticals, the course provides an overview of the related product vigilance areas, such as medical devices, over-the-counter products, and drug/device combinations. In addition to understanding the regulatory framework, additional instruction will include discussions of partnership agreements, pharmacovigilance aspects of due diligence, licensing and acquisitions, and product liability issues.

5589. Advanced Topics in Regulatory Aspects of Biomedical/Technical Communication
Prerequisite: Pharmaceutics 5459, 5592, 5534 or permission of the instructor.
This course is an in-depth discussion of regulatory writing, including responding to FDA or Regulatory Agency Inquiries on Scientific Reports, methods and validation reports for submission, IND Technical Summaries, overviews of NDA preparation (including style/editing of NDA assembly), CMC section of an NDA, the Investigator’s Brochure (ICH Guidelines), the expert report for the European Union applications, developing product label package inserts and Physician’s Desk Reference monographs. 
Formerly Pharmaceutics 589. Not open to students who have taken Pharmaceutics 589.

5591. Global Regulatory Affairs
Prerequisite: Pharmaceutics 5592, 5459, or permission of the instructor.
This course provides a detailed analysis of the regulatory processes for new drug approvals outside of North America. Students gain experience in comparing the European and Japanese registration trends with those of the US. Future regulatory structures in the major world markets are explored. 
Formerly Pharmaceutics 591. Not open to students who have taken Pharmaceutics 591.

5592. Food and Drug Law I
This course studies the governance of intra- and interstate commerce in foods, drugs, cosmetics, and medical devices and the effects of the Federal Food, Drug and Cosmetic Act upon research, manufacture, marketing, and distribution of drugs. 
Note: this course is required for the MS in QA/RA, the Drug Development Certificate, and the Medical Device Certificate.
Formerly Pharmaceutics 592. Not open to students who have taken Pharmaceutics 592.

5594. Regulation of Dietary Supplements, Botanicals and Nutraceuticals
The course focuses on legal issues surrounding the regulation of dietary supplements, nutraceuticals, and botanicals. When does a dietary supplement become a drug under the Federal Food, Drug and Cosmetic Act? What are the legal requirements for labeling? How are claims treated? These topics, along with current issues related to the regulations of dietary supplement are explored. The impact of the Dietary Supplement Health and Education Act, the Federal Food, Drug and Cosmetic Act, the FDA Modernization Act (FDAMA), and other relevant laws are examined. The enforcement authority of other federal regulatory agencies, that is, the FDA and the Federal Trade Commission, is detailed.
Formerly Pharmaceutics 594. Not open to students who have taken Pharmaceutics 594.

5595.  Food Law
While Food and Drug Law I (Pharmaceutics 5592) briefly touches on food law, this course examines the major federal statutes and regulations applicable to food in more detail.  While emphasis is placed on the role, policies, and regulations of the U.S. FDA, the practical working relationships and obligations between the food industry, the USDA, and other government entities are also examined.  Recent efforts to respond to and combat food-borne illnesses are discussed, along with reporting requirements and recalls of defective or injurious products and micro-contamination.  The courses examines the quality practices respected and utilized by FDA and USDA in the regulation of the global food supply.  The instructor also presents pertinent landmark judicial decisions and concepts relating to interstate commerce, corporate and individual responsibility, labeling and promotion, and importation/exportation of products that have direct applicability towards the regulation of medical products.

5596. Food Labeling and Regulatory Affairs
This course provides students with an in-depth understanding about how food in the U.S. must be labeled regardless of its country of origin.  It examines the roles and procedures of the principal regulators (U.S. Food and Drug Administration and the U.S. Department of Agriculture) and their  interaction with the regulated industry and third party peripherals, including consultants and analyzing laboratories.  Students will learn about problems associated with incorrect or deceptive labeling, including the risks to consumers and food manufacturers, marketers and sellers.  Finally the impact of recent or impending legislation or regulations for food businesses regulated by FDA will be discussed.  Students will learn to identify the critical components of a food product’s label, gain knowledge in the laws and regulations governing food labeling, and understand the intricacies of recalls and market withdrawals.

5599. Clinical Aspects of Pharmaceutical Medicine I
This course offers students a basic understanding of the disease processes most prevalent in Western culture. Students gain an appreciation for the epidemiology and demographic patterns of disease and their societal and economic impact. In addition, students gain a basic understanding of the etiology and the pathophysiology underlying the disease processes and the role of pharmacologic intervention. Students may take Pharmaceutics 5599 and 5602 in either order.
Formerly Pharmaceutics 599. Not open to students who have taken Pharmaceutics 599.

5601. Industry Interactions with FDA and Health Authorities
Presenting a global perspective by reviewing the drug approval process in the European Union (EU), this course introduces students to the importance of establishing liaisons with officials with the U.S. FDA and other world health authorities. The rapport developed with health authorities frequently lessens the time it takes to get a new drug to market. How a firm presents its data can contribute as much to the successful relationship with health authorities as the quality of data presented. Areas include: FDA organization, average workload analysis with FDA, FDA review and drug approval process, national versus mutual recognition versus centralized approval process in the EU, user fees, company “personalities,” FDA/Industry meetings, inspections, Advisory Committees, IND/NDA classification system, FDA initiatives to speed drug approval including electronic submissions, and notable internet regulatory addresses.
Formerly Pharmaceutics 601. Not open to students who have taken Pharmaceutics 601.

5602. Clinical Aspects of Pharmaceutical Medicine II 
Students study key areas of clinical medicine and scientific topics such as genetics, gastroenterology, obstetrics and gynecology, medical ethics, hepatology, and emergency medicine.  This course includes new issues and updates in specialties such as cardiology and oncology.  Students may take Pharmaceutics 5599 and 5602 in either order. Formerly Pharmaceutics 602.  Not open to students who have taken Pharmaceutics 602.

5605. Advanced Topics in Food and Drug Law
Prerequisite: Food and Drug Law I (Pharmaceutics 5592) or permission of the instructor.
This course expands the regulatory concepts covered in Pharmaceutics 592. Each semester the specific topics change.
Formerly Pharmaceutics 605. Not open to students who have taken Pharmaceutics 605.

5611. Advanced Topics: Regulation of Advertising & Promotions
This course reviews the regulatory and legal fundamentals of advertising FDA-regulated products, including prescription pharmaceuticals, OTCs, and biologicals. Discussions will include how these regulations differ from those applicable to restricted medical devices and food products.
Formerly Pharmaceutics 611. Not open to students who have taken Pharmaceutics 611.

5612. Bioethics for Pharmaceutical Professionals
This course focuses on bioethical issues arising in the regulation and conduct of research. It instills a basic understanding of bioethics and the theories and principles underlying its practices and application to research. It also discusses how bioethical theories and principles provide the foundation for many research regulations. Starting with a brief history of research ethics and regulation, it explores past and present ethical research controversies.
Note: this course is required for the Certificate in Clinical Trial Management.
Formerly Pharmaceutics 610. Not open to students who have taken Pharmaceutics 610.

5615. Project Management for Pharmaceutical Professionals
Prerequisite: at least four courses in the QA/RA program, including Drug Development (Pharmaceutics 5459) and Food and Drug Law (Pharmaceutics 5592).
This course discusses the strategic positioning of drugs, specifically focusing on domestic and international registration strategies. It explores why a company seeks a particular indication in labeling and how RA/QA professionals play a critical role in understanding and developing regulatory intelligences. It covers how project teams should be created, including the effective clarification of roles and responsibilities, so regulatory timeliness can be achieved. Workshops include an overview of project planning tools, techniques and critical path management, including negotiating registration strategies with the FDA and foreign agencies.
Formerly Pharmaceutics 615. Not open to students who have taken Pharmaceutics 615.

5618. Clinical Data Management 
Prerequisite:  Pharmaceutics 5459 and 5536
Data management is the activity of collecting, reviewing, organizing, and analyzing data from clinical research studies.  The data from clinical research studies are the crux of a regulatory submission for a new drug or biologic.  There is no basis for a therapeutic claim without data.  Thus the success of a submission depends on quality data management practices and strict adherence to regulatory requirements.  This course teaches students how to go from collecting data for the first protocol to ultimate submission to a regulatory agency from data collection, management, and reporting perspectives. 
Note:  this course is required for the Certificate in Clinical Trial Management. Formerly Pharmaceutics 618.  Not open to students who have taken Pharmaceutics 618.

5622.  Unit Operations
Prerequisites:  Students are expected to have a strong science background, including familiarity with chemistry, biology, and physics. Students should also have a basic understanding of pharmaceutical manufacturing processes. In addition, students need an aptitude in basic mathematical principles, including the ability to do calculations.
This course will expose students to the current process steps common to the manufacture of modern pharmaceuticals.  In particular, the key variables for each step of a process will be discussed. Each class will feature a specific process common to pharmaceutical processing.  Specific variables will be discussed, including an analysis of each process.
At the end of the course the student should be able to describe a process by a series of smaller operations, describe the key variables for each small operation, identify key limitations of time and resources in proposed processes, and provide constructive improvements to complex processes.

5625. Process Analytical Technology (PAT)
Prerequisite: Students are expected to have a science background, including familiarity with chemistry. Students should also have a basic understanding of pharmaceutical manufacturing activities.
The course provides an immersion in topics associated with Process Analytical Tecnology (PAT) with the intention of creating a pragmatic working knowledge of the subject. It will cover the regulatory environment, quality control and assurance aspects, business drivers, analytical methodologies (e.g., spectroscopy, chromatography, and sensors), chemometics and multivariate analysis, process conrol, real-time release, and a range of applications (e.g., biologics, vaccines, and solid dose pharmaceuticals). Innovative and abstract thinking will be emphasized.

5627. Statistical Design of Experiments (DOE)
Prerequisite:  familiarity with basic math.  A statistical program (Minitab) will be used.
This course exposes students to the use of statistical methods for designing optimal processes used in industry, extensively using data sets and data charting.  At the end of the course the student should be able to: create an experimental plan to optimize a process; create a screening study to limit the number of experiments; use surface methodology to set process specifications; and use specialized methodology for material analysis.

5629. Process Monitoring
To learn more about this class: http://qara-apache.temple.edu/snee/pm5629_files/default.htm
Students are introduced to state-of-the art process monitoring and controls used in the pharmaceutical and biotechnology industries. Students will be shown how process control is an integral part of using Quality by Design to build quality into the product. A discussion of process flowcharting and improvement is followed by an introduction to the use of control charting and process capability analysis to assess the stability and capability of processes. These concepts, methods and tools are then integrated into a process performance and product quality monitoring and improvement system. The course concludes with an introduction to process improvement using lean and Six Sigma methods. The Minitab statistical software is used to enable the statistical calculations involved. Students deepen their understanding of the subject by completing a project that involves the collection and analysis of data measuring the performance of an operational process. At the end of the course students will be able to collect process monitoring data, analyze process data to assess process stability and capability, identify opportunities for improvement, conduct studies to solve problems and create process improvements, and use statistical software to analyze process data.

5650.  Special Topics in QA/RA
Special topics in QA/RA (described in further detail in the schedule of classes).
For B Berger’s Section:
This course provides an in-depth look at current issues impacting the pharmaceutical and medical device industries.  It examines issues from a regulatory, legal, business, and policy perspective, involved in advertising, clinical research, import/export, preemption, new labeling requirements, anti-kickbacks, counterfeiting, and privacy.  The class explores current legislative and regulatory events as they occur.  A seminar experience, which is more in-depth than introductory courses, this class is comprised of individual and group analysis and includes a required group project and individual paper.

For M. Arentz’s section:
This seminar-style class will examine many of the hot topics facing the medical device industry today.  Topics will include proposed reforms to the 510(k) process, (examining IOM’s report and FDA’s response), development of assurance cases for software validation, FDA’s proposed recision of 510(k) clearances, and mandatory recalls for prior models of devices when new ones are approved.  It will also examine the recent use of increased enforcement through warning letters to the industry.  

5655. Analytical Chemistry in Pharmaceutical Laboratories
Prerequisite:  Drug Development (5459).  Students are expected to have some laboratory background in chemistry or related science and familiarity with laboratory practices.
Analytical chemistry plays a critical role in pharmaceutical product development. An effective laboratory system must ensure that quality data is generated, so that raw materials and finished products can be released. The analytical chemist develops methods, evaluates data, reports results, and writes development reports, according to regulation and compliance standards.
This course provides an overview of laboratory operations and the critical role of an analytical scientist. It reviews regulatory requirements for pharmaceutical lab operations and provides a framework for quality in a drug development laboratory. Although the course is designed for pharmaceutical scientists, many of the operations discussed are applicable to the chemical and environmental industries.

8004. Pharmaceutical Manufacturing II: Solid Dosage Forms
This course presents processing and principles that apply to solid dosage form design and product development.  Conventional and specific techniques of industrial pharmacy, including direct compression, wet and dry granulation, fluid bed and coating operations, tableting machine instrumentation and compactibility measurements, and solid product evaluations are presented.  Novel oral dosage forms and technologies associated with solid products as well as product quality and performance assessment are covered. Formerly Pharmaceutics 407.  Not open to students who have taken Pharmaceutics 407.

Pharmaceutical Sciences Courses
The following courses from the non-thesis MS program in Pharmaceutics are open to QA/RA students with strong science backgrounds. This consists of a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. QA/RA students must fax their resume to 267.468.8565 for written permission to register.

5492. Production of Sterile Parenterals
This course reviews the theory and practice involved in the preparation of sterile, injectable products, covering formulation, manufacturing, facility requirements, validation and regulatory issues. Upon completion of the course, students will develop an understanding of the routes of administration of injectable drugs and the types of injections, current formulation methods, aseptic manufacturing processes, requirements for sterile manufacturing facilities, and validation, compliance and regulatory issues.
Formerly Pharmaceutics 492. Not open to students who have taken Pharmaceutics 492.

5501. Development of Sterile Parenterals
A study of the theory and practice in the development of parenteral products; dosage form design, formulation, solubility/physical pharmacy, excipients, assays, stability, physiochemical properties of biomolecules, delivery systems for controlled/sustained release and manufacturing methods.
Formerly Pharmaceutics 501. Not open to students who have taken Pharmaceutics 501.

8002. Pharmaceutical Analysis
The applications of chemical analysis to pharmaceuticals and pharmaceutical manufacturing are discussed. Classical separation methods, including GC, HPLC, and NMR, as well as hyphenated techniques (GC-MS and HPLC-MC), are explored. Students are introduced to immunologic, antibody-based procedures and emerging technologies.
Formerly Pharmaceutics 411. Not open to students who have taken Pharmaceutics 411.

8003. Pharmaceutical Manufacturing I: Preformulation/Formulation
This course presents techniques relevant to all aspects of preformulation and formulation phases, including specifics of powder characterization, properties of particulate systems for manufacturability, milling, evaluation of crystal structures, thermal methods, DSC, and amphorates, hygroscopic potential of solids during processing, polymorphism, solubility, compactibility, relevant biopharmaceutical factors, dissolution rates as well as principles and mechanisms of all aspects of incompatibility and stability testing.
Formerly Pharmaceutics 406. Not open to students who have taken Pharmaceutics 406.

8004. Pharmaceutical Manufacturing II: Solid Dosage Forms
This course presents processing and principles that apply to solid dosage form design and product development.  Conventional and specific techniques of industrial pharmacy, including direct compression, wet and dry granulation, fluid bed and coating operations, tableting machine instrumentation and compactibility measurements, and solid product evaluations are presented.  Novel oral dosage forms and technologies associated with solid products as well as product quality and performance assessment are covered. Formerly Pharmaceutics 407.  Not open to students who have taken Pharmaceutics 407.

8005. Pharmaceutical Biotechnology
This course introduces students to pharmaceutical biotechnology, biophysical and chemical aspects of biotech products, and their pharmaceutical formulations and clinical applications. Amino acids, proteins, peptides and nucleotides are of particular interest. The principles of pharmaceutical formulations and physicochemical evaluation of formulations will be extensively discussed. Pharmacokinetics of biologics and current analytical methods used in pharmaceutical biotechnology are included. 
Formerly Pharmaceutics 475. Not open to students who have taken Pharmaceutics 475.

8006. Physical Pharmacy I
Prerequisites: Students are expected to have a strong science and math background and a previous course in physical chemistry.
The emphasis of this course is to form a bridge between the concepts of physical pharmacy and the application of pharmaceutical sciences. Students will gain understanding of the aspects of intermolecular forces, physical properties of solutions, ionic equilibria, buffers and isotonic solutions, solubility and partition pharnomena, complexation and protein binding, reaction kinetics, mass transport, dissolution phenomena, interfacial phenonmena, and rheology. Pharmaceutical applications based on the basic principles will be discussed as well. Students will be expected to be able to apply the basic concepts from this course to typical formulation and stability issues of pharmaceutical dosage forms. Formerly Pharmaceutics 485. Not open to students who have taken Pharmaceutics 485.

8007. Applied Biopharmaceutics
This course presents the interrelationship of the physicochemical properties of the drug and the dosage form to the route of administration to the rate and extent of systemic drug absorption. It covers drug absorption mechanisms and physiological and GIT constraints on dosage form transit and bioavailability, effect of formulation parameters, dissolution methodologies, in-vitro/in-vivo correlation of drug product performance, as well as PAC, ICH and FDA guidelines on development and approval processes. Formulation strategies are provided for optimum therapeutic outcome via application of pharmaceutical sciences to the design of drug delivery systems.
Formerly Pharmaceutics 410. Not open to students who have taken Pharmaceutics 410.

8111.  Introduction to Toxicology
Toxicology is a multi-disciplinary science focused on the adverse effects of chemicals, drugs, and environmental agents. In the first part of this course the basic principles of toxicology will be covered, including dose response relationships, mechanisms of toxicity and exposure.  In the second part, target organs of toxicity will be presented with an overview of anatomy and physiology of different target organs (e.g. liver, kidney), as well as organ-specific response to toxic insult.  In the final segment, students will be exposed to a variety of areas of applied toxicology, including risk assessment, clinical and forensic toxicology, chemical carcinogenesis, reproductive toxicology and the role of toxicology in drug development.

8478. Modified Release Dosage Forms
This course covers the fundamentals of various extended release dosage forms and their modification for use in particular dosage formulations. Biopharmaceutical and pharmacokinetic aspects of extended-release dosage forms are discussed, including an overview of polymeric excipients used in formulations. Current commercial products under development are included.
Formerly Pharmaceutics 478. Not open to students who have taken Pharmaceutics 478.

8582.  Physical Pharmacy II
This course focuses on the theory and application of pharmacokinetics (PK) and pharmacodynamics (PD) and PK-PD modeling. Topics include linear and nonlinear PK, compartmental and non compartmental modeling, metabolite kinetics, modeling
concepts, and PK-PD.

Special Note:
The following QA/RA courses may be taken as electives for students pursuing the Non-Thesis Master’s in Pharmaceutics:

5451. Statistical Quality Control
5469. Pharmaceutical Laboratory Quality Systems and Operations
5474. Process Validation
(Students may take 5474 in QA/RA or 8484 in Non-thesis, but they may not receive credit for both courses.)
5477. Good Manufacturing Practices OR 5479. Advanced GMPs – Defining “c” (Students may select 5477 or 5479 but not both courses.)
5478. High Purity Water Systems
5493. Sterilization Processes
5499. Pharmaceutical Drug Dosage Forms
5501. Development of Sterile Parenterals
5512. Microbiological Concepts in Pharmaceutical Manufacturing
5575. Regulatory Sciences: Managing the Guidelines for Quality
5576. Global CMC Issues and Regulatory Dossiers
5622. Unit Operations
5625. Process Analytical Technology (PAT)
5627. Statistical Design of Experiments (DOE)
5629. Process Monitoring
5655. Analytical Chemistry in Pharmaceutical Laboratories