Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials

Drug Information Journal

Volumn 45, Issue 5, 2011, Pages 587-594

  Girman, Cynthia J ^a   Ibia, Ekopimo ^a   Menjoge, Shailendra ^b   Mak, Carmen ^a   Chen, Joshua ^a   Agarwal, Anupam ^c   Binkowitz, Bruce ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^c PFIZER INC   (United States)

Author keywords

Endpoint; Hypothesis testing; Multiregional clinical trial

Indexed keywords

RNA;

CLINICAL TRIAL (TOPIC); FOOD AND DRUG ADMINISTRATION; HEALTH PROGRAM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOTHESIS; LONG TERM CARE; MULTIREGIONAL CLINICAL TRIAL; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; STUDY DESIGN; TREATMENT RESPONSE;

EID: 84864817073     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151104500608     Document Type: Review

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