REGS 631 DRUG AND BIOLOGICS DEVELOPMENT
Drug candidates and active pharmaceutical ingredients (API's) need to be successfully delivered and must exhibit acceptable toxicology. This course follows drug discovery and examines key aspects of drug development, including drug formulation and quality, stability testing, pharmacokinetic characterization, bioequivalence, preclinical toxicology, methods of bioanalysis, and non-clinical and clinical Good Laboratory Practices (GLPs). Aspects of biologics are also discussed.