Population exposure required to assess clinical safety: Report to the international conference on harmonization working group

Drug Information Journal

Volumn 30, Issue 1, 1996, Pages 17-27

  Brown, Jeffrey S ^a   Kaitin, Kenneth I ^a   McAuslane, Neil ^b   Thomas, Kate E ^b   Walker, Stuart R ^b  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Ctr for Medicines Res Intl   (United Kingdom)

Author keywords

Clinical trials; ICH; Population exposure; Safety monitoring; Serious adverse event

Indexed keywords

BIOLOGICAL FACTOR; CARDIOVASCULAR AGENT; CENTRAL NERVOUS SYSTEM AGENTS; GASTROINTESTINAL AGENT; NONSTEROID ANTIINFLAMMATORY AGENT;

ANEMIA; DEPRESSION; DRUG EXPOSURE; DRUG INDUCED DISEASE; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; GASTROINTESTINAL HEMORRHAGE; HUMAN; LUNG TOXICITY; MELENA; PRIORITY JOURNAL; REVIEW; STOMACH ULCER;

EID: 0030029010     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000103     Document Type: Review

References (2)

1. Proceedings of the First International Conference on Harmonization, Brussels, 1991. Edited by D'Arcy, PF Harron DWG. Belfast, N. Ireland: The Queen's University of Belfast, 1992.
2. Gordon AJ Petrick RJ. Worldwide regulations for manufacturers on clinical safety surveillance of drugs. Drug Inf J. 1992 Jan-Mar;26(1):1-15.