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- W1559984168 abstract "The fascination of drug discovery and development for toxicologists is that drugs are intended to have a biological function. Much of the discussion relates to small molecules although in some cases the same concepts can be applied to biotechnology-derived products such as monoclonal antibodies. The Food and Drug Administration (FDA) regulations require that the “safety and efficacy” of a drug be demonstrated prior to marketing approval. For the toxicologist, the design and conduct of nonclinical studies to demonstrate the safety of the drug prior to entry into a clinical trial is of prime importance. With the completion of the toxicology and pharmacology studies, the toxicologist is often charged with recommending and, more importantly, justifying the first-in-human (FIH) dose. Two approaches have been adopted for determining the FIH dose for most therapeutics: no observed adverse effect level (NOAEL) and minimal anticipated biological effect level (MABEL)" @default.
- W1559984168 created "2016-06-24" @default.
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- W1559984168 date "2013-03-11" @default.
- W1559984168 modified "2023-09-26" @default.
- W1559984168 title "Food and Drug Administration: Nonclinical Program and Pharmaceutical Approval" @default.
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- W1559984168 doi "https://doi.org/10.1002/9781118517000.ch3" @default.
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