The ability of animal studies to detect serious post marketing adverse events is limited

Regulatory Toxicology and Pharmacology

Volumn 64, Issue 3, 1970, Pages 345-349

  van Meer, Peter J K ^a   Kooijman, Marlous ^b   Gispen de Wied, Christine C ^c   Moors, Ellen H M ^b   Schellekens, Huub ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

Animal studies; Non clinical drug development; Pharmacovigilance; Predictive value; Regulatory science; Serious adverse reactions

Indexed keywords

ANIMAL EXPERIMENT; ARTICLE; DRUG DEVELOPMENT; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; NONHUMAN; POSTMARKETING SURVEILLANCE; PREDICTIVE VALUE; PRIORITY JOURNAL; REGISTER; ANIMAL; ANIMAL MODEL; DRUG DESIGN; DRUG SCREENING; HUMAN; METHODOLOGY; SPECIES DIFFERENCE;

DRUG;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; HUMANS; MODELS, ANIMAL; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; SPECIES SPECIFICITY;

EID: 84868305913     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.09.002     Document Type: Article

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