Investigation and Need of Bioequivalence Study: Methodology and Regulatory Requirement

Author(s): Uzma Farooq, Rishabha Malviya, Pramod Kumar Sharma.

Journal Name:Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 1 , Issue 2 , 2014

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Abstract:

Bioavailability and bioequivalence studies play a major role in the drug development phase for both new formulations and their generic equivalents. There are various investigations to assess bioequivalence and each regulatory authority has its own guidance for the conduction of bioavailability and bioequivalence studies before approval of generic products. Bioequivalence studies are the primary needs for generic products to enter in the market. The manufacturer’s (generic product) must be in limit with that of innovator (branded) formulation (reference listed drug). This review deals with methods of bioavailability studies and requirement of bioequivalence studies necessary for filing of data for the approval of formulation.

Keywords: Bioavailability, bioequivalence, generic drug, in vitro and in vivo, pharmacokinetic, regulatory requirement, therapeutic equivalence.

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Article Details

VOLUME: 1
ISSUE: 2
Year: 2014
Page: [93 - 106]
Pages: 14
DOI: 10.2174/2213476X01666140613221900
Price: $58