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- W4290803611 abstract "Phase 4 trials are often conducted as post-marketing efforts to further evaluate the characteristics of the new drug regarding safety, efficacy, new indications for additional patient populations, and new formulations. While life cycle management may be at the core of the new formulations and indications efforts, Phase 4 clinical trials in special populations are often conducted as expected fulfillment of regulatory requirements and a condition of approval and market access. Other post-marketing trials, including drug surveillance or real-world evidence trials, are conducted to confirm safety and effectiveness in real-world patients that likely fall outside of the range of patients considered for Phase 3 trials. The term “Special Populations” originated as a means to define patient subpopulations outside the “mainstream” patient population – typically defined as the targeted (or “to be enrolled”) Phase 3 population. The most considered special populations include geriatrics, pediatrics, pregnant women, and organ impairment (typically, renal and hepatic impairment)." @default.
- W4290803611 created "2022-08-12" @default.
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- W4290803611 date "2022-08-11" @default.
- W4290803611 modified "2023-10-16" @default.
- W4290803611 title "Phase 4, Special Populations and Post‐marketing" @default.
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- W4290803611 doi "https://doi.org/10.1002/9781119913276.ch10" @default.
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