ICH-E9 reflections and considerations

Pharmaceutical Statistics

Volumn 7, Issue 4, 2008, Pages 233-235

  Rockhold, Frank W ^a   Ruberg, Stephen J ^b  

^a GLAXOSMITHKLINE   (United States)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DOCUMENTATION; DRUG INDUSTRY; DRUG MANUFACTURE; GEOGRAPHIC INFORMATION SYSTEM; MEDICAL EDUCATION; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; PUBLICATION; SCIENTIST; STATISTICS;

ANNIVERSARIES AND SPECIAL EVENTS; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS AS TOPIC; HUMANS; RESEARCH DESIGN;

EID: 57849132631     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.345     Document Type: Article

References (6)

1. SFDA. Guidelines for statistical principles in clinical trials. 2005.
2. Chen F, Chen Q, Chen J, Hsu J. 2007. Current statistical requirements for pharmaceutical clinical trials in China. DIA Journal (in press).
3. Points to Consider - Missing Data - EMEA/CHMP/EWP/439980/2007.
4. Points to Consider on Adjustment for Baseline Covariates CPMP/EWP/2863/ 99.
5. Points to Consider - Switching between Superiority and Non-inferiority CPMP/EWP/482/99.
6. ICH E10 2000. Choice of control group in clinical trials. Available at URL: http://www.ich.org/LOB/media/MEDIA486.pdf [14 April 2008].