新药质量控制研究与质量标准制订之漫谈.pptVIP

新药质量控制研究 和质量标准制订之漫谈 中国医学科学院药物研究所  General D Process =)=)〓)洲)2))m)m)mm)m)) Chemand Pharm. Processing /Manut. Development, Processing and Manutacturing  he Roles of Structure Analysis Group in drug development ase Discovery aunch Support NDA Support Toxicology ualify Primary Reference Standard NDA proof of Structure Cofa for tox. lot Forced Degradation study otential impurities support purities and Degradation product Support Release testing 1ll CofA preformulation preliminary reference Clinical supplies testing Support Marketing standard Investigation of oOS IND Proo