Introduction to the drug discovery, development, and approval pathways used in the United States with a specific focus on career pathways related to pharmaceutical development, including the natural and biomedical sciences, clinical, regulatory and legal affairs, sales and marketing, and business development.
Introduction to drug discovery, development, and approval process in the United States with a focus on preclinical and clinical development activities and the role of the FDA and other regulatory bodies in the approval and oversight of available drug products.
Basic concepts of cell culture, animal models, and biochemical techniques for mechanistic evaluation of drug actions.
An introduction to drug absorption, distribution and elimination processes controlling overall drug exposure in humans. Basic quantitative measurements will be presented and used to demonstrate the influence of drug properties and physiologic action on drug disposition.
Collection and interpretation of analytical data; instrumental analysis and separation techniques.
PHAR:4736 Properties of Dosage Forms I (1st half Fall semester!) - 2 s.h.
Introduction to principles of physical and chemical sciences important in drug product development; solubility, colligative properties, and partitioning behavior, as well as ionic equilibria, pH control, and chemical stability are evaluated in context of their importance in liquid dosage forms; emphasis on issues impacting drug product quality.
Physical and chemical properties and measurements of materials used in pharmaceuticals; introduction to material properties of drugs and excipients used in development of semi-solid and solid pharmaceuticals; emphasis on material selection, dosage form performance characteristics, and evaluation of drug product quality.
Different types of materials used in drug and gene delivery including synthetic and natural polymers (poly lactic-co-glycolic acid and chitosan respectively); different forms of delivery systems including (but not limited to) liposomes, micelles, biodegradable nanoparticles, nondegradable nanoparticles, and solid porous scaffolds; applications of these material-based delivery systems from targeted chemotherapy to bone regeneration to vaccination applications.
Advanced design and development of drug delivery systems; emphasis on selection of materials and designs suitable for specific applications; comparison and evaluation of available and emerging technologies.
Introduction to design of drug molecules based on an understanding of drug-like properties including chemical reactivity and structural optimization; minimization of potentially toxic biotransformations; optimization of absorption; screening methods for selection and classification of optimized molecules.