Nontraditional Study Designs for Proving Bioequivalence
Movva Snehalatha PhD (Pharmacy), Research and Development – Generics, Dr. Reddy’s laboratories Ltd, Hyderabad, India
- *Corresponding Author:
- Dr. Movva Snehalatha PhD (Pharmacy)
Research and Development – Generics
Dr. Reddy’s laboratories Ltd
E-mail: [email protected]
Received Date: November 23, 2011; Accepted Date: December 03, 2011; Published Date: December 05, 2011
Citation: Latha S (2011) Nontraditional Study Designs for Proving Bioequivalence. J Bioequiv Availab 3: ix-000. doi: 10.4172/jbb.1000000e9
Copyright: © 2011 Latha S. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
From past many years, concerns have been expressed regarding meeting the standard bioequivalence (BE) criteria for highly variable drugs. This has been point of discussion in many conferences and meetings. But to date there is no as such regulatory definition for these drugs or drug products. To pass conventional goal posts for these drugs, the number of subjects required for a study can be much higher than normally needed for a typical BE study. The resources required and the ethical concerns of exposing large number of healthy volunteers to a test drug further poses challenge to the suitability of conventional BE criteria (with an 80-125% acceptance range) for highly variable drugs. Examples exist where a highly variable reference product failed to demonstrate BE when compared to itself in a bioequivalent study using the standard design/sample size.