BPS 2110 Study Guide - Midterm Guide: Hmg-Coa Reductase, Bioequivalence, Generic Drug

• School: University of Ottawa
• Department: Biopharmaceutical sciences
• Course: BPS 2110
• Professor: Gabriel Guillet

Document Summary

How many people are typically involved in each phase: approximately what percent of drugs entering phase i clinical trials are eventually approved by. Why is this important in insuring drug safety: despite the results of the clinical trial studies and the effort of regulatory agencies some drugs are withdrawn within a few years of approval. Question 4: explain the basic concept upon which the development of cholesterol lowering drugs (statins) is based, a japanese company started to look for possible natural inhibitors of hmd-coa reductase. Briefly explain why the looked first at metabolites produced by micro-organisms and not metabolites produced by plants: which part (s) of the structure of mevastatin are considered crucial for the inhibition of hmg- Explain by drawing chemical structure of a the natural ligand of this enzyme. [hint: take into account the structure of mevastatin and its open chain form]