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Demonstrating bioequivalence using clinical endpoint studies
Article first published online: 13 MAR 2012
Published 2012. This article is a U.S. Government work and is in the public domain in the USA
Journal of Veterinary Pharmacology and Therapeutics
Special Issue: Bioequivalence
Volume 35, Issue Supplement s1, pages 31–37, April 2012
How to Cite
BERMINGHAM, E., Del CASTILLO, J. R. E., LAINESSE, C., PASLOSKE, K. and RADECKI, S. (2012), Demonstrating bioequivalence using clinical endpoint studies. Journal of Veterinary Pharmacology and Therapeutics, 35: 31–37. doi: 10.1111/j.1365-2885.2012.01366.x
- Issue published online: 13 MAR 2012
- Article first published online: 13 MAR 2012
- (Paper received 15 December 2011; accepted for publication 16 December 2011)
Bermingham, E., del Castillo, J. R. E., Lainesse, C., Pasloske, K., Radecki, S. Demonstrating bioequivalence using clinical endpoint studies. J. vet. Pharmacol. Therap.35 (Suppl. 1), 31–37.
For drug products not amenable to blood level studies, clinical endpoint studies have been used as an indirect measure of formulation difference in bioavailability between test and reference products. However, clinical endpoint studies are not as sensitive in detecting formulation differences as blood level studies and offer numerous challenges to both regulatory authorities and sponsors. The objective of this article is not to suggest new regulatory policies, but to explore new methodologies and alternative solutions to clinical endpoint bioequivalence (BE) studies, which are used when a blood level study is not considered to be appropriate. To achieve this objective, this article identifies situations where a clinical endpoint study might be appropriate, lists the advantages and disadvantages of this type of study design, and discusses possible alternative solutions. It is concluded that future evidence-based research is needed to explore new methodologies such as clinical trial simulations of various study designs, new statistical methods, and new in vitro methods to demonstrate BE.