This course gives an overview of drug discovery principles and techniques for the practicing medicinal chemist.

Topics include mechanisms immediate and sustained drug release in formulations; novel drug delivery systems; drug pre-formulation; the drug approval process; drug preparation, liberation, absorption and stability of dosage forms.

An overview of USFDA's regulation on drug. Topics covered include pharmaceutical regulatory agencies and organizations around the world and their International Regulatory Audits for Pharma, International Conference on Harmonization (ICH) guidelines, Pharmacopoeias and national formulary, US Food and Drug Administration (USFDA): History of USFDA Law and Regulation, GLP, MMP, NDA, and ANDA.

The course will help graduate students in the pharmaceutical sciences learn the basics of scientific communication and how to critically evaluate scientific literature. This 1 credit hour course is repeatable for credit up to 4 times.

Topics covered include the concepts and mechanisms of the basic processes underlying disease and pathophysiology; the general principles underlying drug action and therapeutics, including receptor pharmacology, enzyme inhibition and pharmacology; the relationship between drug concentration at the target tissue and drug effect; as they relate to drug action and individual variation in response.

Topics covered include the physicochemical principles of pharmacy, such as acid-base theory, solubility, physical states of drugs, thermodynamics, drug stability, excipients, surfactants, dispersions, polymers, drug delivery, chemical compatibility and interactions of drugs in various dosage forms.

Topics covered include mechanisms of both immediate and sustained drug release in formulations involving solid and semi-solid systems; introduction to novel drug delivery systems; drug pre-formulation, the drug approval processes, and regulations governing the pharmaceutical industry; drug preparation, liberation, absorption and stability dosage.

Special Topics

Independent Study

Problem Report

Product Development by Quality by Design

Independent Study

Problem Report

Thesis