Statistical issues in biologics submissions to the FDA

Drug Information Journal

Volumn 30, Issue 4, 1996, Pages 921-932

  Lynch, Cornelius J ^a   Lachenbruch, Peter A ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Clinical trials; IND; PLA; Regulatory review; Statistics

Indexed keywords

CLINICAL TRIAL; DRUG ANALYSIS; DRUG RESEARCH; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; LABORATORY TEST; LICENSING; PRIORITY JOURNAL; REVIEW;

EID: 0029806818     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000408     Document Type: Review

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