How do Food and Drug Administration (FDA) regulations and guidelines drive the drugdevelopment pathway for small-molecule products? We will outline the guidelines and regulations for pharmaceutical products including requirements for non-Good Laboratory Practice (GLP) and GLP safety studies, Absorption, Distribution, Metabolism and Excretion (ADME), Pharmacokinetic-Pharmacodynamic (PK/PD), and other pharmacokinetic and toxicological studies to establish the safety and efficacy of drugs as dictated by FDA regulations. Students will learn how to utilize safety (NOEL/”No Observed Effect Level” and NOAEL/”No Observed Adverse Effect Level”), efficacy, and pharmacokinetic studies to determine first in human doses and a therapeutic index, and requirements for Good Manufacturing Practices (GMP). Students will also learn about small, niche FDA regulatory pathways to include the animal rule (in which humans cannot be included in efficacy studies for safety reasons)/animal model development through discussions of biological warfare and outbreak pathogen therapeutic development.
CH 562: Drug Development Pathways for Therapeutics
Department