Issues in clinical trial design from the FDA perspective

Epilepsia

Volumn 44, Issue SUPPL. 7, 2003, Pages 9-15

  Katz, Russell ^a  

^a Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT;

CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; EPILEPSY; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGULATORY MECHANISM;

EID: 0042416548     PISSN: 00139580     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1528-1157.44.s7.7.x     Document Type: Conference Paper

References (14)

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12. Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials. U.S. DHHS, FDA, CDER, CBER May 2001; ICH.
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14. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: practical issues and specific cases. Ann Intern Med 2000;133:455-63.