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- W2317967893 abstract "The safety assessment of pharmaceutical agents is a highly specialized process that is required by regulatory agencies prior to their approval for marketing of a drug. In general, an evaluation of the safety of pharmaceutical agents can be roughly divided into two phases: the preclinical or nonclinical phase and the clinical phase. The nonclinical phase progresses from the initial physical and chemical characterization of an agent through an increasingly complex series of animal toxicity studies, while clinical studies test the new drug product in progressively larger numbers of human beings. However, safety assessment represents only one segment of the development process for pharmaceutical products. This chapter is intended to guide the reader through the general requirements for nonclinical or experimental animal safety testing in order to gain drug approval in the United States, European Union, and Japan." @default.
- W2317967893 created "2016-06-24" @default.
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- W2317967893 date "2010-01-01" @default.
- W2317967893 modified "2023-09-26" @default.
- W2317967893 title "Safety Assessment of Pharmaceuticals*" @default.
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- W2317967893 doi "https://doi.org/10.1016/b978-0-08-046884-6.00303-1" @default.
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