Bioequivalence and Bioavailability Studies: Regulatory Assessment and Study Design Considerations and Pharmacokinetic Parameters
1, 1
- 1Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, INDIA.
CORRESPONDENCE
Atharva Surendra Bhalerao
Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, INDIA.
Received: 09-05-2025; Revised: 28-07-2025; Accepted: 15-09-2025.
Volume 60, Issue 2 · pp. 460-466 · 2026 · 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).
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Bhalerao, A. S., & Sonawane, S. (2026). Bioequivalence and Bioavailability Studies: Regulatory Assessment and Study Design Considerations and Pharmacokinetic Parameters. Indian Journal of Pharmaceutical Education and Research, 60(2), 460-466. https://doi.org/10.5530/ijper.20260065
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This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0