Document Detail

A method of designing clinical trials for combination drugs.
MedLine Citation:
PMID:  1496194     Owner:  NLM     Status:  MEDLINE    
Many pharmaceutical companies are now exploring combination drug therapies as an alternative to monotherapy. Consequently, it is of interest to investigate the simultaneous dose response relationship of two active drugs to select the lowest effective combination. In this paper, we propose a method for designing clinical trials for drug combinations that seems to offer several advantages over the 4 x 3 or even larger factorial studies that have been used to date. In addition, our proposed method provides a convenient formula for calculating the required sample size.
J G Pigeon; M D Copenhaver; J P Whipple
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  11     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1992 Jun 
Date Detail:
Created Date:  1992-09-08     Completed Date:  1992-09-08     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1065-74     Citation Subset:  IM    
Department of Mathematical Sciences, Villanova University, PA 19085.
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MeSH Terms
Clinical Trials as Topic / standards*
Dose-Response Relationship, Drug
Drug Therapy, Combination*
Models, Statistical*
Research Design / standards*

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