EMEA 人用药品委员会(CHMP)《遗传毒性杂质限度指导原则》原文：European Medicines Agency: Guideline on the Limits of Genotoxic Impurities. CPMP/SWP/5199/02。EMEA/CHMP/QWP/251344/2024。London, 28 June 2024摘要遗传毒性杂质的毒理学评估和原料药中此类杂质的...

时间:2025-06-25 13:35栏目:行业资料

EMEA 人用药品委员会(CHMP)《遗传毒性杂质限度指导原则》原文：European Medicines Agency: Guideline on the Limits of Genotoxic Impurities. CPMP/SWP/5199/02。EMEA/CHMP/QWP/251344/2006。London, 28 June 2006摘要遗传毒性杂质的毒理学评估和原料药中此类杂质的...

时间:2025-03-09 09:35栏目:综合大类