制药工程专业英语Unit 5.pptVIP

评价新化学实体的通用指南应该是一个为期14天以上毒理学研究需要支持正常的志愿者在第I阶段的单剂量接触一个新的候选药物。支持7至10天时间的临床研究，要求为期30天的毒理学研究。而超过7至10天直至30天的临床研究则需要有至少90天的毒理学研究的支持。 A general guide for the evaluation of new chemical entities would be that toxicology studies of a minimum duration of 14 days are required to support single-dose exposure of a new drug candidate in normal volunteers in Phase I. Toxicology studies of 30 days duration are required to support clinical studies of 7 to 10 days duration. Clinical studies of greater than 7 to 10 days up to 30 days duration require the support of at least 90 days toxicology studies.