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- W2060648508 abstract "f you ask people familiar with I clinical research or drug development about the phases of clinical research, they will readily recite the following: Phase 1 studies are safety and pharmacokinetic studies in normal volunteers; Phase 2 are pilot safety and efficacy studies in patients; Phase 3 are pivotal safety and efficacy studies in patients; and Phase 4 are post-approval studies. This simple categorical system is evidenced in the U.S. Food & Drug Administration (FDA) Form 1571 for an Investigational New Drug (IND) application and amendments. Section 8 asks to list “Phase(s) of clinical investigation to be conducted.” There are boxes for Phase 1, 2, 3, or “other.” However, in 1997, the International Conference on Harmonisation, a consortium of drug developers and regulatory scientists from Japan, Europe, and North America, took the following position in the E8 “General Considerations for Clinical Trials” guidance: “It is important to recognize that the phase of development provides an inadequate basis for classification of clinical trials because one type of trial may occur in several phases (Figure 1). It is important to appreciate that the phase concept is a description, not a set of requirements. It is also important to realize that the temporal phases do not imply a fixed order of" @default.
- W2060648508 created "2016-06-24" @default.
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- W2060648508 date "2014-10-01" @default.
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- W2060648508 title "Phases of Clinical Development" @default.
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- W2060648508 doi "https://doi.org/10.1016/j.jtos.2014.07.001" @default.
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