Bioequivalence and Bioavailability Studies: Regulatory Assessment and Study Design Considerations and Pharmacokinetic Parameters

Indian Journal of Pharmaceutical Education and Research

  • Atharva Surendra Bhalerao1Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, INDIA.
  • Sandeep Sonawane1Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, INDIA.

Volume 60 Issue 2 Pages 460-466

DOI: 10.5530/ijper.20260065

Abstract

Bioequivalence and bioavailability studies are vital components of the pharmaceutical industry, ensuring the safety, efficacy and interchangeability of generic drugs compared to their reference products. This comprehensive research paper dives deeper into the concepts of the principles of bioequivalence and bioavailability. The application of the Biopharmaceutics Classification System (BCS) in evaluating bioequivalence, different study designs used in these assessments. A thorough review of bioequivalence evaluation in line with guidelines from the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA).

Keywords

  • Bioequivalence
  • Study Design
  • EMA
  • USFDA.
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