Significance of BA/BE Studies

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. Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other. For multisource products bioequivalence studies/bioequivalence assessment conferences are necessary to ensure therapeutic equivalence and interchange ability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

  • 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

Related Conference of Significance of BA/BE Studies

July 03-04, 2017

4th Annual Congress on Drug Discovery & Designing

Bangkok, Thailand
August 10-12, 2017

8th Asian Biologics and Biosimilars Congress

Beijing, China
September 20-21, 2017

10th Pharmacovigilance Congress

Charlotte, North Carolina, USA
September 25-26, 2017(10 Plenary Forums- 1 Event)

7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Chicago, Illinois, USA
September 25-26, 2017
(10 Plenary Forums - 1Event)

6th International Conference and Exhibition on GMP, GCP & Quality Control

Chicago, Illinois, USA
October 02-04, 2017

World Congress on Antibiotics: R&D, Market

Atlanta, USA
October 16-18, 2017

12th World Pharma Congress

Budapest, Hungary
October 16-18, 2017

11th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
Baltimore, Maryland, USA
October 16-17, 2017

10th International Conference and Exhibition on Biologics and Biosimilars

San Francisco, California, USA
November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria

Significance of BA/BE Studies Conference Speakers

Recommended Sessions

Related Journals

Are you interested in