Document Detail


Demonstrating bioequivalence using clinical endpoint studies.
MedLine Citation:
PMID:  22413789     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
E Bermingham; J R E Del Castillo; C Lainesse; K Pasloske; S Radecki
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of veterinary pharmacology and therapeutics     Volume:  35 Suppl 1     ISSN:  1365-2885     ISO Abbreviation:  J. Vet. Pharmacol. Ther.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-03-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7910920     Medline TA:  J Vet Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  31-7     Citation Subset:  IM    
Copyright Information:
Published 2012. This article is a U.S. Government work and is in the public domain in the USA.
Affiliation:
Division of Therapeutic Drugs for Non-Food Animals, FDA Center of Veterinary Medicine, Rockville, MD, USA Department de Biomédecine Vétérinaire, Université de Montréal, St-Hyacinthe, Québec, QC, Canada Clinical Evaluation Division, Veterinary Drugs Directorate, Health Canada, Ottawa, ON, Canada Jurox Pty Ltd., Rutherford, NSW, Australia Statistical Consultant, Petoskey, MI, USA.
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