A History of Biopharmaceutics in the Food and Drug Administration 1968–1993
Journal Title: The AAPS Journal - Year 2010, Vol 12, Issue 1
Abstract
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.
Authors and Affiliations
Jerome Philip Skelly
Keywords
Related Articles
- EP ID EP681359
- DOI 10.1208/s12248-009-9154-8
- Views 54
- Downloads 0
Evaluation of the Microcentrifuge Dissolution Method as a Tool for Spray-Dried Dispersion
Although using spray-dried dispersions (SDDs) to improve the bioavailability of poorly water-soluble compounds has become a common practice in supporting the early phases of clinical studies, their performance evaluation...
Bioerodible injectable poly(ortho ester) for tetracycline controlled delivery to periodontal pockets: Preliminary trial in humans
The semisolid consistency of poly(ortho esters) (POEs) containing tetracycline free base allows direct injection in the periodontal pocket and shows sustained and almost constant in vitro release in phosphate buffer, pH...
Pharmacokinetics of the time-dependent elimination of all-trans-retinoic acid in rats
The time-dependent elimination kinetics of all-transretinoic acid (ATRA) has been associated with autoinduction of its metabolism and has led to the hypothesis that rapid development of acquired clinical resistance to AT...
Challenges and Opportunities in Absorption, Distribution, Metabolism, and Excretion Studies of Therapeutic Biologics
With the advancement of biotechnology in the last two decades, optimized and novel modalities and platforms of biologic moieties have emerged rapidly in drug discovery pipelines. In addition, new technologies for deliver...
Physiochemical and Biochemical Factors Influencing the Pharmacokinetics of Antibody Therapeutics
Monoclonal antibodies are increasingly being developed to treat multiple disease areas, including those related to oncology, immunology, neurology, and ophthalmology. There are multiple factors, such as charge, size, neo...