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Applied Clinical Research, Clinical Trials and Regulatory Affairs
ISSN (Print): 2213-476X
ISSN (Online): 2213-4778
Epub Full Text Article
DOI: 10.2174/2213476X01666140613221900      Price:  $95









Investigation and need of Bioequivalence Study: Methodology and Regulatory Requirement

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Author(s): Uzma Farooq, Rishabha Malviya and Pramod Kumar Sharma
Abstract:
Bioavailability and bioequivalence studies play a major function 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 (generic) 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, regulatory requirement, generic drug, pharmacokinetic, therapeutic equivalence, in-vitro and in-vivo
Affiliation:
Research Scholar, Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Plot No. 2, Sector 17-A, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India.