CDER/FDA formats for submission of animal carcinogenicity study data

Drug Information Journal

Volumn 32, Issue 1, 1998, Pages 43-52

  Lin, Karl K ^a  

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

Author keywords

Death rate method; Divisions of Biometrics formats; Onset rate method; Prevalence method; Statistical reviews; STUDIES formats

Indexed keywords

CARCINOGENICITY; DATA ANALYSIS; DOSE RESPONSE; DRUG INFORMATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MORTALITY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; STATISTICAL ANALYSIS;

EID: 0031917473     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159803200107     Document Type: Review

References (13)

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12. U.S. Department of Health and Human Services, Food and Drug Administration. Formats and Specifications for Submission of Animal Carcinogenicity Study Data. Divisions of Biometrics I, II, III, and IV, Center for Drug Evaluation and Research. Rockville, Maryland; March 12, 1997.
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