参考文献 一、FDA有关指导原则 1、Guidance
for Industry. BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives
Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation. FDA
February 2001. 2、Guidance for Industry. Changes to an Approved NDA or ANDA. U.S. Department
of Health and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research (CDER). November 1999 3、SUPAC-IR: Immediate-Release
Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation (I)
11/30/1995 4、SUPAC-MR: Modified Release
Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation (I)
10/6/1997 5、SUPAC-SS: Nonsterile
Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Release Testing and In Vivo
Bioequivalence Documentation (I)
6/13/1997 6、Dissolution
Testing of Immediate Release Solid Oral Dosage Forms. U.S.
Department of Health and Human Services. Food and Drug Administration. Center
for Drug Evaluation and Research (CDER). 7、Extended
Release Oral Dosage Forms: Development, Evaluation, and Application of In
Vitro/In Vivo Correlations. U.S. Department of
Health and Human Services. Food and Drug Administration. Center for Drug
Evaluation and Research (CDER). 8、Guidance for
Industry: Bioavailability and Bioequivalence Studies for Orally Administered
Drug Products — General Considerations. U.S. Department of Health and Human
Services. Food and Drug Administration. Center for Drug Evaluation and Research
(CDER). March 2003 BP (Revision 1). 9、Waiver
of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. U.S. Department of Health and Human Services.
Food and Drug Administration. Center for Drug Evaluation and Research (CDER). 二、EMEA有关指导原则 10、Guideline on Dossier
Requirements for Tyle IA and Type IB Notifications. European Commission. July 2003. 11、Guideline on Stability Testing for Applications for Variations
to A Marketing Authorisation. CPMP
December 2003. 12、Note for Guidance on The Investigation of Bioavailability and
Bioequivalence. CPMP/EWP/QWP/1401/98. 三、TGA有关指导原则 13、Appendix 12: Changes To Pharmaceutical And Quality
Information Of Registered Medicinal Products: Notification, Self-Assessment And
Prior Approval. Australian Regulatory Guidelines For Prescription Medicines 14、Appendix
11b: Policy
On When To Request Bioavailability Data (Or A Justification As To Why Such Data
Are Not Required). Australian Guidelines
For The Registration Of Drugs . 15、Appendix 15:
Biopharmaceutical Studies. Australian
Regulatory Guidelines For Prescription Medicines . 四、ICH有关指导原则 16、ICH Q6a. Specifications: Test
procedures and acceptance criteria for new drug substances and new drug
products: Chemical substances. Draft ICH Consensus Guideline. 五、其他 18、《化学药物制剂研究的基本技术指导原则》 19、“关于加强药品规格和包装规格管理的通知”。食药监注函（2004）91号。 20、“关于药品改变规格有效期及已有国家标准品种有效期确定的会议纪要”，药品审评中心，2003年7月。 名词解释 最后一步反应中间体 本指导原则中最后一步反应仅限于形成共价键的反应，成盐等反应不包括在内。 著者 《已上市化学药品变更研究的技术指导原则》课题研究组 |
