Bioequivalence requirements of Pharmaceutical Products in US, Europe and Australia

  • Nishi Patel
  • Jimesh Shah
  • Amit Patel Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa
  • Ravish J. Patel


In the last three decades, the notion of bioequivalence has gotten a lot of attention as it has been applied to new branded and generic medications. Generic medications must meet the same quality, efficacy, and safety requirements. Conventional products should be therapeutically equal to the reference product and compatible. The evolution of regulatory standards for bioequivalence in the United States, Europe, and Australia are examined in this paper. There is no international harmonization of regulatory requirements for bioequivalence, but the scope of bioequivalence and statistical analysis is partially harmonized; however, there are differences in applying single-dose trials and in vitro dissolution tests due to subject selection and reference product selection. The drug management system and drug regulating laws determine the pharmaceutical market's share. A bioequivalence study is one of the essential elements in the generic medicine approval process. The plasma time-concentration curve is frequently used in bioequivalence studies to determine absorption pace and absorption. The bioequivalence of the goods examined can be determined using the selected pharmacokinetic parameters and predefined acceptability thresholds. Recent advancements and information on crucial areas of bioequivalence study design and specification recommendations for each endpoint are included in this review.

Keywords: Bioequivalence, Bioavailability, Pharmacokinetics, Fasting and Fed Studies, ICH GCP, biowaiver, Biopharmaceutics Classification System (BCS), USFDA, EMA, TGA


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How to Cite
Patel, N., J. Shah, A. Patel, and R. J. Patel. “Bioequivalence Requirements of Pharmaceutical Products in US, Europe and Australia”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 2, June 2022, pp. 56-61, doi:10.22270/ijdra.v10i2.524.