游牧 发表于 2025-3-21 18:27:21
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Recruitment of Subjects,The recruitment of subjects must be considered very carefully to ensure that sufficient persons with the characteristics required by the investigators are enrolled within an appropriate period of time. The number of subjects is of great importance and was discussed in chapter 6.Reservation 发表于 2025-3-22 05:57:54
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,The Conduct of the Trial — Good Clinical Practice,are foreseen and taken into account of prior to the start of the trial and those that are unexpected. Murphy’s law states, “..” This law has been attributed to captain E Murphy, a development engineer, who applied it first to an individual technician saying, “.” .某人 发表于 2025-3-22 18:09:59
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Early Trials on New Drugs, three phases of early trials: trials to determine safety and early clinical pharmacology (phase I); trials to determine clinical efficacy and further clinical pharmacology (phase II); and trials for the early clinical development of the drug (phase III). A drug regulatory authority may be involved in these early trials.Brittle 发表于 2025-3-23 03:56:45
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asurement of the benefit:risk comparison; determination ofcost- effectiveness and cost utility; stopping rules for trials;meta-analysis and subgroup analysis are all new sections. Thereferences are expanded from 305 to 512 and include the recentadvances in trial design, such as the .n.-of-1 trials a