Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A

Journal of Pharmacological and Toxicological Methods

Volumn 52, Issue 1, 2005, Pages 22-29

  Valentin, Jean Pierre ^a   Bass, Alan S ^b   Atrakchi, Aisar ^c   Olejniczak, Klaus ^d   Kannosuke, Fujimori ^e  

^a ASTRAZENECA   (United Kingdom)

^b MERCK RESEARCH LABORATORIES   (United States)

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

^d Federal Institute for Drugs and Medical Devices   (Germany)

^e PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOOD LABORATORY PRACTICE; MEDICAL SOCIETY; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; STATISTICAL ANALYSIS;

EID: 22444432917     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2005.04.009     Document Type: Article

References (24)

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