顾夕DrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm
27、Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Generic Drugs. Filing Review of Abbreviated New Drug Applications, MAPP 5200.14. September 2017.
28、European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on In-use Stability Testing of Human Medicine Products. September 2001.
29、European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicine Products. January 1998.
为更好地服务申请人开展化学药物注射剂一致性评价工作，总局一致性评价办公室将组织对上述参考文献进行翻译，及时在药品审评中心网站公开。
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