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ISSN 2063-5346
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A REVIEW ON BIOEQUIVALENCE STUDY: IN VITRO-IN VIVO CORRELATION

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Naman1, Mansi Garg1, Shweta Mishra1
» doi: 10.48047/ecb/2023.12.si5a.0476

Abstract

Bioequivalence studies play an important role in the pharmaceutical industry for the development of a pharmacological formulation. The monitoring of pharmacokinetic and pharmacodynamic variables following the administration of tested medications serves as their justification. The goal of such research is to assess the therapeutic compatibility of tested medications (pharmaceutical equivalents or pharmacological alternatives). The importance of bioequivalence studies is growing as the manufacture and usage of generic products grows. Together with the pharmaceutical quality data of the medical product, the search results of the bioequivalence research make up one of the major components of the registration file submitted to a national regulatory authority. It is recommended that a bioequivalence research be used to compare the original and the generic product is sufficient. The objective of present review article is to inform the medical community about the different kinds of bioequivalence studies, their application, and guidelines for their use, and to help them form their own opinions about the matter.

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