Premium
Translational Toxicology and the Work of the Predictive Safety Testing Consortium
Author(s) -
Mattes WB,
Walker EG
Publication year - 2009
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/clpt.2008.270
Subject(s) - safety pharmacology , human health , medicine , human use , harmonization , food and drug administration , pharmacology , occupational safety and health , drug , toxicology , environmental health , microbiology and biotechnology , biology , pathology , physics , acoustics
Toxicology has always been translational—at least with respect to its primary focus on human “health.” The earliest “toxicologists” explored the effects of plant and animal poisons on humans, conducting experiments on (often unsuspecting) human subjects. 1 Not until the sulfanilamide disaster of 1937, the 1938 US Federal Food, Drug and Cosmetic Act, and the Nuremberg Code did animals become central to the experimental assessment of chemical safety. 2 , 3 Now, with harmonization of requirements among various international regulatory agencies, the types and design of safety evaluation studies conducted to support first‐in‐human investigations have been reasonably standardized. 4 Most drug safety studies are conducted in both a rodent and a nonrodent species, with the aim of identifying adverse reactions relevant to human health, potential target organs of toxicity, a dose for first‐in‐human studies, a margin of safety between the efficacious and toxic doses, and strategies for monitoring safety during clinical trials. 5 Clinical Pharmacology & Therapeutics (2009); 85 , 3, 327–330 doi: 10.1038/clpt.2008.270