To this end, sufficient documentation of the comparative analytical performance results and the clinical performance results for the safety and efficacy of the drug should be provided in the summary of product characteristics (SmPC).20 The MFDS specifies that, if an IVD-CDx that is scheduled for ...
转化为特定制剂质量标准限度(单位ppm)是将上述对应限度(ng)除以指定药品SmPC中载明的最大日剂量(mg)得到的。 • The limit as calculated above will usually need to be included in the finished product specification. •上述计算所得限度通常需要放在制剂质量标准中 • Skip testing is only justified if...