Why BA/BE Studies

Why BA/BE Studies Submit Abstract Register Now

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme.

Global BA/BE studies market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

  • Analysis of BA/BE by oral vs parentral
  • Criterion for bioequivalence confidence interval approach
  • Parametric vs non-parametric tests
  • Bioequivalence of endogenous substances
  • Plasma concentration vs time curve (AUC) based dosing
  • Adverse drug reactions
  • In narrow therapeutic index drugs

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