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- W4251897930 abstract "pharmacovigilance (PV) heavily focuses on adverse drug reactions (ADRs) which are defined as any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. The basic unit of all postmarketing safety submissions is the adverse drug experience “case”, which is an individual adverse drug experience. A postmarketing adverse drug experience source can be categorized into the several sample categories: clinical trial, nonclinical trial/regulatory authority, nonclinical trial/literature, and nonclinical trial/all other. This chapter deals with spontaneous experiences-nonclinical trial adverse drug experiences reported to the industry any time after a marketed drug product achieves marketing approval from Food and Drug Administration (FDA). In principle, there is nothing new about the idea that FDA will be analyzing postmarketing safety reports for new drugs." @default.
- W4251897930 created "2022-05-12" @default.
- W4251897930 date "2016-10-31" @default.
- W4251897930 modified "2023-09-26" @default.
- W4251897930 title "POSTMARKETING SAFETY EVALUATION" @default.
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- W4251897930 doi "https://doi.org/10.1002/9781119097440.ch29" @default.
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