Pharmaceutical Development and Review Process.pptVIP

Pharmaceutical Development and Review Process Rev. 10/21/2014 APGO Interaction with Industry: A Medical Student Guide Objectives Learn the processes involved in drug discovery and development in the United States Understand the role of the Food and Drug Administration FDA in the drug development and review process in the US Define the phases involved in FDA drug approval Overview-Research and Development Process RD Development of new drugs is a complex and costly process It takes an average of 9 years and $850 million to take a “chemical entity” from the lab to the pharmacy shelf RD involves discovery, preclinical studies and development One out of every 1,000 compounds that begin preclinical studies will ultimately be marketed Brief Flow Diagram of the Drug Approval Process Preclinical/animal studies Investigational new drug IND application Clinical studies Phases 1-3 New drug application FDA/CDER review Approval Post approval evaluation/Phase 4 A History of Federal Oversight of the Drug Development Process The Food and Drug Administration FDA is the Federal agency that is required by law to review and approve all new drugs in the US. The 1906 Food and Drugs Act prohibited mislabeling but did not require pre-market approval of drugs. The 1938 Food, Drugs and Cosmetics Act required submission of evidence of a drug’s safety before it could be marketed. The Role of the FDA The FDA reviews and evaluates new drugs based on evidence presented from the clinical research studies performed by the drug sponsor-typically a pharmaceutical company The Center for Drug Evaluation and Research CDER is the largest of the FDA’s five centers and is responsible for prescription and over-the-counter OTC drug safety and efficacy Preclinical Studies Synthesis and purification of the new drug Pharmacology of the new drug: Pharmacokinetics: absorption, distribution, metabolism, excretion, half-life Pharmacodynamics: mechanism of action and estimates of therapeutic effec