A history of biopharmaceutics in the Food and Drug Administration 1968-1993.
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions it was to have, and the implementation of that authority are described. The determination of bioequivalence, the bioavailability decision rules, pharmacokinetics, and drug metabolism are explained. The reason for the development of the Scale-Up and Post Approval Regulations and how they were developed are also explained.
Skelly
Jerome Philip
JP
jeromepskelly@verizon.net
D001682:Biological Availability; D001702:Biopharmaceutics / Q000266:history*; D002568:Certification; D049673:History, 20th Century; D004364:Pharmaceutical Preparations / Q000378:metabolism; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history* / Q000331:legislation & jurisprudence
D004364:Pharmaceutical Preparations