相容性研究中几个关键阈值的简介及转换
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摘要
目的:通过相容性研究中可提取物与浸出物评估方法研究和评估阈值的转换,将化学物质的毒理学数据转换为化学物质的分析数据,从而实现药品与包装材料相容性研究中对浸出物的控制。方法:文献查阅,汇总美国产品质量研究学会(PQRI)毒理学家和化学家们确定的几个重要概念、关键阈值,并举例说明。结论:为药品研发及生产过程中对药品及包装系统的可提取物与浸出物进行研究和控制提供明确的思路和方法。
Objective: By developing the evaluation methods and the conversion from SCT to AET of the extractable and leachable in the compatibility,the toxicological data can be converted to analysis data of chemicals,so we can control the leachables in compatibility studies. Methods: Literature review,and the summary of several important concepts and key threshold identified by the toxicologists and chemists from PQRI,and make examples. Conclusion: To provide clear ideas and methods for the research and control of extractables and leachables in the process of drug development and production.
Objective: By developing the evaluation methods and the conversion from SCT to AET of the extractable and leachable in the compatibility,the toxicological data can be converted to analysis data of chemicals,so we can control the leachables in compatibility studies. Methods: Literature review,and the summary of several important concepts and key threshold identified by the toxicologists and chemists from PQRI,and make examples. Conclusion: To provide clear ideas and methods for the research and control of extractables and leachables in the process of drug development and production.
引文
[1]Douglas Ball,Daniel Norwood,Cheryl Stults:Leachables and Extractables Handbook:Safety evaluation,Qualification,and Best Practices Applied to Inhalation Drug Products[M].2011.
[2]Daniel Norwood,Diane Paskiet,Michael Ruberto.Best practices for extractables and leachables in orally inhaled and nasal drug products:an overview of the PQRI recommendations:Pharmaceutical Research[EB/OL].[2008-04].http://link.springer.com/journal/11095.
[3]Dennis Jenke:Compatibility of Pharmaceutical Products and Contact Materials:Safety Considerations Associated with Extractables and Leachables[M].2008.
[4]国家食品药品监督管理局.化学药品注射剂与塑料包装材料相容性研究技术指导原则(试行)[S].2012.
[5]《化学药品注射剂与药用玻璃容器相容性研究技术指导原则》(征求意见稿)[S].国家食品药品监督管理局[EB/OL].[2013-03-08].http://www.cde.org.cn/zdyz.domethod=largePage&id=199.
[6]Daniel Norwood,Lee Nagao and Cheryl Stults.Perspectives on the PQRI Extractables and Leachables“Safety Thresholds and Best Practices”Recommendations for Inhalation Drug Products:PDA J Pharm Sci and Tech[EB/OL].[2013-05].http://journal.pda.org/content/67/5/413.full.pdf+html.
[7]Douglas Ball,James Blanchard,David Jacobson-Kram.Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal:Drug Product Evaluation[EB/OL].[2007-02].http://www.pqri.org/structure/technical.asp.
[2]Daniel Norwood,Diane Paskiet,Michael Ruberto.Best practices for extractables and leachables in orally inhaled and nasal drug products:an overview of the PQRI recommendations:Pharmaceutical Research[EB/OL].[2008-04].http://link.springer.com/journal/11095.
[3]Dennis Jenke:Compatibility of Pharmaceutical Products and Contact Materials:Safety Considerations Associated with Extractables and Leachables[M].2008.
[4]国家食品药品监督管理局.化学药品注射剂与塑料包装材料相容性研究技术指导原则(试行)[S].2012.
[5]《化学药品注射剂与药用玻璃容器相容性研究技术指导原则》(征求意见稿)[S].国家食品药品监督管理局[EB/OL].[2013-03-08].http://www.cde.org.cn/zdyz.domethod=largePage&id=199.
[6]Daniel Norwood,Lee Nagao and Cheryl Stults.Perspectives on the PQRI Extractables and Leachables“Safety Thresholds and Best Practices”Recommendations for Inhalation Drug Products:PDA J Pharm Sci and Tech[EB/OL].[2013-05].http://journal.pda.org/content/67/5/413.full.pdf+html.
[7]Douglas Ball,James Blanchard,David Jacobson-Kram.Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal:Drug Product Evaluation[EB/OL].[2007-02].http://www.pqri.org/structure/technical.asp.