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Preclinical Predictors of Clinical Safety: Opportunities for Improvement
Author(s) -
Sistare F D,
DeGeorge J J
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100243
Subject(s) - clinical pharmacology , safety pharmacology , preclinical testing , drug development , medicine , risk analysis (engineering) , drug , relevance (law) , clinical toxicology , pharmacology , intensive care medicine , medical physics , toxicology , biology , political science , law
Toxicology studies in animals are required by regulatory authorities worldwide to provide assurances that clinical testing of pharmaceutical candidates can be conducted safely. 1 Safety concerns from animal studies account for over 20% of attritions from drug development. 2 As discordance between humans and animals is expected, two goals of safe and efficient drug development must be (1) to improve the human relevance of animal testing with new models and technologies, and (2) to advance quickly to clinical testing armed with improved safety biomarker tools. Clinical Pharmacology & Therapeutics (2007) 82 210–214. doi: 10.1038/sj.clpt.6100243 ; published online 16 May 2007