Bioavailability and bioequivalence: The past, present and costly affairs of a global concept used locally

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The information on recommendations for conductance of bioavailability and bioequivalence is required for filing of Investigational New Drug, New Drug Application and Abbreviated New Drug Application. The guidelines for these studies differ as the drug product applicant moves from one country to the other. A sound knowledge of these is therefore mandatory for availing the benefits of timely and economic drug product approvals. The current scenario of the bioavailability and bioequivalence studies has its roots in the age old years where the Upjohn's friable pills reflected the desire for efficient drug delivery. The scientific developments date back to the late 1950's and early 1960's with the landmark Kefauver Harris Amendments and the Hatch-Waxman Act. The fast pace pharmaceutical industry is exploring the vistas for drug discovery and innovation. The pharmaceutical firms all over the world are burning the candle at both ends for attainment of market authorizations in various nations. This review explores the history of the bioavailability and bioequivalence studies. In addition it details the important aspects of these studies in the United States, European Union, South Africa, India, ASEAN and Brazil. The study highlights the global pharmaceutical expenditures and depicts current market scenario along with statistics up to 2013 for global generics market. The study concludes to suggest the harmonization of bioavailability and bioequivalence studies worldwide for achieving the benefits of what the author labels as the three M's - service to mankind, monetary gains and saving of precious minutes.

Harbola P.



Secondary Title

International Journal of Pharmaceutical Sciences Review and Research


Global Research Online









Bioavailability, Bioequivalence, Hatch-Waxman Act, Pharmaceutical expenditure, Regulatory guidelines, generic drug, article, drug bioavailability, economic aspect, government, health care concepts, history of medicine, practice guideline, United States

Form: Journal Article
Geographical Area: Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Other

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