NAPSRx Certification Exam Study Guide Chapter 9

Most recent studies have estimated the cost of bringing a new drug to market is how much? - $1..5 - 1.8 billion For every 5,000-10,000 compounds that enter R&D, how about many are approved by the FDA? - 1 Why have many pharmaceutical R&D processes become longer and more complex? - more complex scientific tools and disease targets more intensive regulatory process growing demand in medical community for more complex data about pharmaceuticals What percent of costs associated with new drug development are spent on Phase III trials? - 90% is a medical reference summarizing standards of drug purity, strength, and directions for synthesis? - Pharmacopoeia a branch of the FDA, that exercises control over whether prescription drugs and OTC drugs may be used in therapy - CDER (Center for Drug Evaluation and Research) states its mission as facilitating the availability of safe, effective drugs, keeping unsafe or ineffective drugs off the market, improving the health of Americans, and providing clear, easily understandable drug information for safe and effective use - Center for Drug Evaluation and Research (CDER) a branch of the FDA that regulates the use of biologics including serums, vaccines, and blood products - CBER (Center of Biologics Evaluation and Research) The FDA oversees administration of herbal products and dietary supplements through who? - CFSAN (Center for Food Safety and Applied Nutrition) Can herbal and dietary supplements be marketed without prior approval by the FDA? - yes What are the 4 phases that therapeutic drugs and biologics are reviewed? - 1) preclinical investigation 2) Clinical investigation 3) Review of NDA (new drug application) 4) Post-marketing surveillance Why are preclinical investigation results always inconclusive? - because animal testing may overestimate or underestimate the actual risk to humans Which phase of drug testing takes the longest? - Clinical Investigation