中美仿制药研发和申报流程概述.pptxVIP

中美仿制药研发和申报流程;;药物经济学催生美国仿制药制度;1984年后;NDA的研发和申报;505(b)(1) 新药申报资料内容;6. Human Pharmacokinetics and Bioavailability 7. Microbiology ( for anti-microbial drugs only) 8. Clinical Data 9. Safety Update report ( typically submitted 120 days after the NDA’s submission ) ;10. Statistical 11. Case Report Tabulations 12. Case Report Forms 13. Patent Information 14. Patent Certification ;505(b)(2): 历史过程;505(b)(2)的关键: 可靠性;505(b)(2)的意义;505(b)(2)范围;505(b)(2)情形;505(b)(2)排他性;505(b)(2)新药的成功例子;505(b)(2)新药的例子;505(b)(2)新药的例子;505(b)(2)新药的例子;FDA NDA 审评过程;FDA 可以使用已有数据用于审评NDA吗？;美国仿制药; Generic drug applications are te