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Gender Differences in Drug Bioequivalence: Time to Rethink Practices.
MedLine Citation:
PMID:  23299647     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Currently, bioequivalence (BE) studies are carried out exclusively in males, assuming that intrasubject variabilities are similar between the sexes. This article challenges this hypothesis on the basis of available evidence and urges that studies of BE of sufficient power be undertaken in women also for all generic drugs aimed at women.Clinical Pharmacology & Therapeutics (2013); advance online publication 9 January 2013.doi:10.1038/clpt.2012.233.
Authors:
G Koren; H Nordeng; S Macleod
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-03
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  -     ISSN:  1532-6535     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2013-1-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Motherisk Program, Division of Clinical Pharmacology/Toxicology, SickKids Hospital, University of Toronto, Toronto, Ontario, Canada.
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