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20141216ICHQ3D元素杂质指南

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物利用度 ≥ 90%: 除以1作为修正因子。РWhere oral bioavailability data or occupational inhalation exposure limits were not available, a calculated PDE was used based on the oral PDE divided by a modifying factor of 100 (Ref. 1).Р如果没有口服生物利用度数据或职业吸入暴露限,则在根据口服PDE值计算出PDE值后除以修正因子100(参考文献1)。Р3.2 Other Routes of Administration 其它摄入途径РPDEs were established for oral, parenteral and inhalation routes of administration. When PDEs are necessary for other routes of administration, the concepts described in this guideline may be used to derive PDEs. An assessment may either increase or decrease an established PDE. The process of derivation of the PDE for another route of administration may include the following:РPDE是针对口服、注射和吸入给药途径建立的。如果需要其它给药途径的PDE,则可以使用本指南的概念来推导PDE。评估结果可能会升高或降低已建立的PDE值。从一种给药途径推导出另一种给药途径的PDE值的计算过程包括以下:

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