针对口服固体制剂技术转让前后质量保持一致的探讨
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摘要
目的:探讨在技术转让实务中对于转让前后产品质量应保持一致的度的把握。方法:从实际案例出发,研读大量法律法规、指导原则及文献,探讨口服固体制剂药品技术转让实务中出现的以下3个问题:①有无必要进行0月溶出曲线对比;②比较对象的选择:商业批还是注册批;③具有参考意义的稳定性数据的合理试验条件的选择。结果与结论:①根据0月检测的两个主要作用,有必要进行0月溶出曲线的对比;②建议将受让方的检测批与转让方的商业批数据进行对比;③具体问题具体分析,综合考虑药品本身特性、批准的有效期及贮藏条件等,选择具有参考价值的试验条件进行数据对比。
Objective: To explore the quality consistency before and after the technology transfer of oral solid preparations. Methods: Based on the actual cases,a large number of laws,regulations,guiding principles and references were studied to discuss the following three problems in the transfer of oral solid preparations: question 1,whether it is necessary to compare the dissolution curve of0 month; question 2,the choice of compared objects,commercial batches or registration batches; question 3,how to choose reasonable conditions for stability testing with reference meaning. Results and Conclusion: Firstly,according to the two functions of detection of0 month,it is necessary to compare the dissolution curves of 0 month. Secondly,it is suggested that the data of samples from transferee be compared with those of commercial batches from transferor. Lastly,it should be analyze specific questions in detail such as drug characteristics,validity period of approval and storage conditions.
Objective: To explore the quality consistency before and after the technology transfer of oral solid preparations. Methods: Based on the actual cases,a large number of laws,regulations,guiding principles and references were studied to discuss the following three problems in the transfer of oral solid preparations: question 1,whether it is necessary to compare the dissolution curve of0 month; question 2,the choice of compared objects,commercial batches or registration batches; question 3,how to choose reasonable conditions for stability testing with reference meaning. Results and Conclusion: Firstly,according to the two functions of detection of0 month,it is necessary to compare the dissolution curves of 0 month. Secondly,it is suggested that the data of samples from transferee be compared with those of commercial batches from transferor. Lastly,it should be analyze specific questions in detail such as drug characteristics,validity period of approval and storage conditions.
引文
1原国家食品药品监督管理总局.国务院印发《关于改革药品医疗器械审评审批制度的意见》[EB/OL].(2015-08-18)[2018-07-06].http://samr.cfda.gov.cn/WS01/CL0051/126861.html
2原国家食品药品监督管理总局.关于印发《药品技术转让注册管理规定》的通知[EB/OL].(2009-08-19)[2018-07-06].http://samr.cfda.gov.cn/WS01/CL0058/40893.html
3谢沐风.改善溶出度评价方法、提高固体药物制剂水平[J].中国医药工业杂志,2005,36(7):447-451
4原国家食品药品监督管理总局.普通口服固体制剂溶出度试验技术指导原则[EB/OL].(2015-02-05)[2018-07-06].http://samr.cfda.gov.cn/WS01/CL1616/114288.html
5谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-311
6谢沐风.如何科学、客观地制订溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):243-252
7 ICH.Harmonised Tripartite Guideline Q1A(R2):Stability testing of new drug substances and products[EB/OL].(2003-02-06)[2018-08-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf
8 ICH.Harmonised Tripartite Guideline Q11:Development and manufacture of drug substances(chemical entities and biotechnological/biological entities)[EB/OL].(2012-05-01)[2018-08-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
9 ICH.Harmonised Tripartite Guideline Q8(R2):Pharmaceutical development[EB/OL].(2009-08-01)[2018-07-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.Pdf
10闫顺华,王秀霞,叶青,等.实验室内外部质量控制活动分析与探讨[J].中国卫生检验杂志,2018,28(14):1786-1789
11王筱婧,王东兴,祝倩,等.药品技术转让质量对比研究的主要内容与关注要点[J].中国医药科学,2016,6(14):221-223
12任连杰,刘涓,马玉楠.仿制药申请注册批次生产规模的思考[J].药学进展,2017,41(10):783-787
13王宏亮,陈震.关于化学药品注册批量问题的探讨[J].中国新药杂志,2016,25(18):2046-2051
14原国家食品药品监督管理总局.化学药物(原料药和制剂)稳定性研究技术指导原则(2015-02-05)[2018-07-06][EB/OL].http://samr.cfda.gov.cn/wsol/CL0087/114286.html
15霍秀敏.稳定性试验与药品的有效期[J].药品评价,2007,4(1):56-58
2原国家食品药品监督管理总局.关于印发《药品技术转让注册管理规定》的通知[EB/OL].(2009-08-19)[2018-07-06].http://samr.cfda.gov.cn/WS01/CL0058/40893.html
3谢沐风.改善溶出度评价方法、提高固体药物制剂水平[J].中国医药工业杂志,2005,36(7):447-451
4原国家食品药品监督管理总局.普通口服固体制剂溶出度试验技术指导原则[EB/OL].(2015-02-05)[2018-07-06].http://samr.cfda.gov.cn/WS01/CL1616/114288.html
5谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-311
6谢沐风.如何科学、客观地制订溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):243-252
7 ICH.Harmonised Tripartite Guideline Q1A(R2):Stability testing of new drug substances and products[EB/OL].(2003-02-06)[2018-08-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf
8 ICH.Harmonised Tripartite Guideline Q11:Development and manufacture of drug substances(chemical entities and biotechnological/biological entities)[EB/OL].(2012-05-01)[2018-08-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
9 ICH.Harmonised Tripartite Guideline Q8(R2):Pharmaceutical development[EB/OL].(2009-08-01)[2018-07-06].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.Pdf
10闫顺华,王秀霞,叶青,等.实验室内外部质量控制活动分析与探讨[J].中国卫生检验杂志,2018,28(14):1786-1789
11王筱婧,王东兴,祝倩,等.药品技术转让质量对比研究的主要内容与关注要点[J].中国医药科学,2016,6(14):221-223
12任连杰,刘涓,马玉楠.仿制药申请注册批次生产规模的思考[J].药学进展,2017,41(10):783-787
13王宏亮,陈震.关于化学药品注册批量问题的探讨[J].中国新药杂志,2016,25(18):2046-2051
14原国家食品药品监督管理总局.化学药物(原料药和制剂)稳定性研究技术指导原则(2015-02-05)[2018-07-06][EB/OL].http://samr.cfda.gov.cn/wsol/CL0087/114286.html
15霍秀敏.稳定性试验与药品的有效期[J].药品评价,2007,4(1):56-58