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The Safety of Medicines: Evaluation and Prediction

Robert C. Hastings, MD, PhD
JAMA. 1981;246(9):1027. doi:10.1001/jama.1981.03320090073042.
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Professor Folb is professor of pharmacology at the University of Cape Town and chief physician at Groote Schuur Hospital in Cape Town, South Africa, with research interests in mechanisms and animal models of drug toxicities. From this authoritative perspective the author has prepared a series of six informative essays describing and commenting on, in layman's language, the subject of drug safety. The underlying theme of the work is that no drug is completely safe and that everyday therapeutics always involves a risk-benefit assessment in clinical practice. The overriding principle in the development of new drugs should be reasonableness rather than wasteful overregulation (and disincentives to drug developers) in an attempt to assure the impossible: a completely safe medication. General principles of drug safety are defined in terms of preclinical animal studies and their extrapolation into early clinical trials of new drugs; these include teratogenic potential, drug dependence, carcinogenic potential, potential


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