502. Advanced Pharmacokinetic Modeling I. (3 s.h.)

Provides the fundamental mathematical basics for the development of pharmacokinetic modes. The underlying assumptions, advantages, and limitations of each model, as well as state-of-the-art data handling will be discussed. Homework problems will be handled using PCNONLIN, and students will be expected to do monoexponential disposition, AUC calculations, moment analysis, computer methods/PCNONLIN, renal clearance, and infusional kinetics.

503. Advanced Pharmacokinetic Modeling II. (3 s.h.)

This course is designed for students who have taken Advanced Pharmacokinetics Modeling I. More advanced mathematical skills to develop pharmacokinetic/pharmacodynamic models and reviews more sophisticated methodology and operation of the methods available in the literature. The underlying assumptions, advantages, and limitations of each method as well as the state-of-the-art of data handling will be presented and discussed to add insight into improved experimental design to obtain optimal pharmacokinetic data and parameters.

506. Industrial Pharmaceutical Technology. (3 s.h.)

Covers advances made in understanding powder behavior and many useful qualitative and quantitative measurements of factors important to industrial pharmacy and product development.

530. Advanced Medicinal Chemistry I. (All lectures) (3 s.h.)

In-depth discussion of the synthesis and structure activity relationships of the major therapeutic classification of drugs.

532. Advanced Medicinal Chemistry II. (3 s.h.)

Discussions of the organic chemistry of drug action and drug design. Current topics in the field are discussed using examples from the recent literature. Synthesis and structure-activity relationships of some current and potential therapeutic drug classes.

547. Polymeric Materials for Pharmaceutical Application. (3 s.h.)

Basic concepts in synthetic polymer science such as synthesis and characterization will be discussed with an emphasis on its application for pharmaceutics and biomaterials. Current developments in polymeric drug delivery systems will be focused upon.

548. Novel Polymeric Drug Delivery Systems: Principles and Applications. (3 s.h.)

Provides the physicochemical principles in the design of polymeric controlled-release dosage forms such as diffusion in polymers, synthetic membranes applicable for drug delivery systems and bio separation, swelling and dissolution of polymers, and others. Topics include the physical systems (reservoir and matrix systems), chemical systems (prodrugs and immobilization systems), and "closed-loop" systems (auto regulation systems).

577. Pharmacodynamics. (2 s.h.)

Designed for industrial scientists who do not have any pharmacodynamic backgrounds. Basic concepts of principles and modeling pharmacodynamics, state-of-the-art techniques in obtaining pharmacodynamic parameters using popular PC software, and interpreting and applying these principles in drug development and clinical settings. Reviews the relationship between plasma concentrations and therapeutic effects for a variety of drugs and discusses their optimization of dosage regimens from the pharmacodynamic point of view.

582. Colloid and Surface Chemistry. (4 s.h.)

Includes the colloidal, interfacial and rheological aspects of disperse systems (suspension, gels, and emulsions), and polymer solutions, surfactants, aerosols and membranes. Physicochemical principles governing the preparation and properties of colloidal systems emphasized.

584. Surfactants. (2 s.h.)

Topics: types and structure of surfactant molecules; properties of aqueous and non-aqueous surfactant solutions; foaming; micelle formation and solubilization. Binary systems; tenary systems; surfactant-water-amphiphile. Stabilization of emulsions and of solid/liquid dispersions. Biological applications.

585. Kinetics in Pharmaceutics. (3 s.h.)

Reviews the processes of pharmaceutical degradation, stability studies, and kinetics and orders of reactions.

587. Polymers: Properties, Packaging and Pharmaceutical Applications. (3 s.h.)

Survey of synthetic and natural polymers. Relation between chemical structure, molecular weight, crystallinity, orientation and the physical, mechanical, and solution properties of polymers. Plastic films and composites used in packaging devices. Thickening agents for solutions and suspension; gel formation.

588. Topics in Pharmaceutical Sciences. (1-3 s.h.)

Topics vary; specific topic(s) announced prior to the start of the semester.

603. Dermatopharmaceutics. ( 3 s.h.)

Study of the physiology, biochemistry, immunology, skin permeability, and penetration enhancers as well as role of growth factors in healing after injuries. Semi-solid products, influence of formulation variables and their overall drug release capacities in-vitro and in-vivo will be evaluated. Transdermal, iontophoresis, sonophoresis topics, and bioequivalence/ bioavailability of topical preparation will be discussed.

699. Master’s Research. (1-6 s.h.)

799. Preliminary Exam Preparation. (1-6 s.h.)

899. Pre-Dissertation Research. (1-6 s.h.)

999. Dissertation Research. (1-6 s.h.)

Quality Assurance/Regulatory Affairs

451. Statistical Quality Control. (3 s.h.)

Introduction to statistical concepts; control charts for variables; probability theory; control charts for attributes; acceptance sampling systems. Class discussions include application to quality control of pharmaceutical manufacturing.

452. Acceptance Sampling. (3 s.h.)

Covers the statistical basis of acceptance sampling plans and schemes and pharmacopocial 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.

459. Drug Development. (3 s.h.)

A study of the drug development process in the pharmaceutical industry from drug discovery through FDA marketing approval. Presents concepts, issues, and interactions with FDA, ICH, and other regulatory agencies.

479. Advanced GMPs-Defining "c". (3 s.h.)

Prerequisite: Successful completion of Pharmaceutics 487 or permission of instructor.

Designed to bring the students from a basic GMP understanding presented in Pharmaceutics 487 to a full 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 will also be discussed.

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