Formerly Pharmaceutics 451. Not open to students who have taken Pharmaceutics 451.
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 487. Not open to students who have taken Pharmaceutics 487.
This course provides an introduction to cGMP (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.
Note: 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 488. Not open to students who have taken Pharmaceutics 488.
This course examines high purity water systems from the 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 489. Not open to students who have taken Pharmaceutics 489.
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 492. Not open to students who have taken Pharmaceutics 492.
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 493. Not open to students who have taken Pharmaceutics 493.
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 499. Not open to students who have taken Pharmaceutics 499.
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 501. Not open to students who have taken Pharmaceutics 501.
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 512. Not open to students who have taken Pharmaceutics 512.
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 580. Not open to students who have taken Pharmaceutics 580.
Prerequisite: permission of instructor required; strong science background required.
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.
8001. Principles of Drug Action/Pharmacokinetics (3 s.h.)
This course presents the fundamental principles of pharmacology, medicinal chemistry, and pharmacokinetics needed to understand their application in drug discovery and developmental processes. The material, presented in an integrated manner, includes the molecular mechanisms of drug action, structure-activity relationships, and the time-course of drug absorption and disposition.
Application of chemical analysis as it relates to pharmaceuticals and pharmaceutical manufacturing. Classical separation methods including GC, HPLC, and NMR as well as, hyphenated techniques (GC-MS & HPLC-MC) will be explored. The student will also be introduced to immunologic antibody based procedures and emerging technologies.
Presents techniques relevant to all aspects of preformulation and formulation phases, as well as principles and mechanisms of incompatibility and stability testing.
8005. Pharmaceutical Biotechnology (3 s.h.)
This course will introduce 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 formulation of biotech products and physicochemical evaluation of formulations will be extensively discussed. Also, pharmacokinetics of biologics and current analytical methods used in pharmaceutical biotechnology will be introduced.
The emphasis of this course is to form bridge between the concepts of physical pharmacy and the application of pharmaceutical sciences. Students will understand basic aspects of intermolecular forces, physical properties of solutions, ionic equilibria, buffers and isotonic solutions, solubility and partition phenomena, complexation and protein binding, reaction kinetics, mass transport, dissolution phenomena, interfacial phenomena, 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. A previous course is physical chemistry.
Presents the interrelationships of the physicochemical properties of the drug and the dosage form, to the route of administration and to the rate and extent of systemic absorption. Drug absorption mechanisms, 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 SUPAC, ICH and FDA guidelines on development and approval process will be covered. Formulation strategies for optimum therapeutic outcome via application of pharmaceutical sciences to the design of drug delivery systems is provided.
Prerequisite: Permission of instructor required
The course is designed for students who either intend to concentrate their research in the area of pharmacokinetics and pharmcodynamics or desire a strong underpinning in pharmacokinetics. The course will provide the mathematical basis for the derivation and development of various pharmacokinetic and pharmacodynamic models. Students will be required to apply pharmacokinetic models via various computer programs to data to generate model parameters. Readings and interpretation of classic and newer literature relevant to pharmacokinetic theory and applications will be required.
Discussions of the organic chemistry of drug action and drug design. Current topics in the field are discussed using examples from the recent literature. The design, synthesis and structure activity relationships for major therapeutic drug classes are discussed in detail.
Continued discussions of the organic chemistry of drug action and drug design with current topics discussed using examples from the recent literature. Students review the current literature, give presentations and write research proposals based on their readings and class materials.
The goal of the course is to expose graduate students in the Department of Pharmaceutical Sciences to the faculty research in our department. Students will be presented with a number of research topics, including pharmaceutics, pharmacokinetics, medicinal chemistry, biotransformation, pharmacology, and physiology. In addition to the presentations by faculty members, several guest speakers will present their research topics and discuss their opinions on science careers outside of academia (i.e., industry, medical writing, medical science liaison, etc.). Through exposure to these diverse research topics, students will become more well-rounded scientists and become more aware of career opportunities that are available to them.
The purpose of this course is to research, write and submit a manuscript (review article) in English for publication in a refereed scientific journal.
8402. Pharmacodynamics (3 s.h.)
This course covers the theoretical underpinnings and practical aspects of quantitative pharmacology. A key feature of the course is its concentration on the integrated study of a drug's pharmacokinetics (transport to its site of action: including absorption, distribution, biotransformation, and excretion) and its mechanism of action at the site of action. Emphasis is placed on the mathematical foundations of such topics as drug-receptor theory, Schild analysis, Furchgott's method, radioligand binding studies, PK/PD modeling, and isobolographic analysis of drug combinations.
The course is a one semester course focused on inherited factors that modulate drug response. Special problems of genetic variability in humans, detection and prediction of pharmacologically relevant genetic polymorphisms will be discussed. The course will integrate current mechanistic knowledge of drugs, human genetics, data mining, and analytical tools to tailor drug administration for a specific genetic background.
This course is to expose graduate students to the current literature in Pharmaceutics, Phamacodynamics and Drug Delivery. The goal of the course is to expose the student to a variety of literature articles pertaining to the physical, biologic, and formulation of pharmaceutical dosage forms.
At the end of the course the student should be able to:
- Compare and critique articles form several journals common to the area of pharmaceutics.
- Analyze literature articles as to the relevancy the results to the discussion.
- Propose new research based on the current literature article
- Be able to write an abstract for a review article based on several publications.
8478. Modified Release Dosage Forms (3 s.h.)
The fundamentals involved in 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 as well. Overview of polymeric excipients used in the formulation of extended-release dosage forms. Current commercial products under development will be discussed.
This course will cover drug transport in biological systems and advanced topics in pharmacokinetics and pharmacodynamics. The course is an extension of 8008 (509), which is a prerequisite for 8502 502), and will also involve computer methods to derive models and discussion of current literature.
Includes the colloidal, interfacial and rheological aspects of disperse systems (suspension, gels, and emulsions), and polymer solutions, surfactants, aerosols and membranes. The rheological behavior of polymer systems will be discussed. The physical chemical properties of proteins and peptides will be presented with formulation applications. This is an advanced course. Physical Pharmacy I is a prerequisite.
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 of the course, students will be exposed to a variety of areas of applied toxicology, including risk assessment, clinical & forensic toxicology, chemical carcinogenesis, reproductive toxicology and the role of toxicology in drug development.
8000. Topics in Pharmaceutical Sciences (1-3 s.h.)
Topics vary; specific topic(s) announced prior to the start of the semester.
9994. Preliminary Exam Preparation (1-6 s.h.)
9996. Master's Research (1-6 s.h.)
9998. Pre-Dissertation Research (1-6 s.h.)
9999. Dissertation Research (1-6 s.h.)