Abstract
It is important to recognize that the new drug development process, which begins with the identification of a potential therapeutic compound, continues well into the post-marketing period. The responsibility of regulators, scientists, physicians, and the pharmaceutical industry to pursue knowledge about drug safety and efficacy extends well beyond the time when sufficient information is available to suggest that a drug is safe and efficacious, and warrants marketing. The ultimate uses of newly marketed medications and the clinical milieu into which it will be interposed is extremely dynamic and complex. It is during the early marketing period that a number of drugs approved for marketing were discovered to have serious, unanticipated adverse events requiring at best a change in labeling; and at worst removal from the market at great cost, in terms of credibility and dollars, to both FDA and the pharmaceutical industry (FDA Drug Review, 1990).
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Grasela, T.H., Antal, E.J. (1993). Pharmacoepidemiology, Population Pharmacokinetics and New Drug Development. In: Yacobi, A., Skelly, J.P., Shah, V.P., Benet, L.Z. (eds) Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-1520-0_16
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