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FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units FDA公布ICH Q4B----附录6：剂型均一性 On 16 June 2014, the FDA published the ICH harmonised Guideline entitled "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter (Q4B Annex 6)". This ICH Guideline thus came into force in the USA, too. 2014年6月16日，FDA公布了题为“在ICH区域采用药典正文剂型均一性通则的评估和建议（Q4B附录6）”的ICH三方协调指南。该ICH指南因此也将在美国实施。 The objective of the ICH Q4B Working Group is to reach mutual recognition by regulatory authorities in the ICH regions for all testing methods listed in the ICH Q6A Guideline on Specifications. Through this, comparable testing laid down in the different pharmacopeias shouldn't be performed separately when it has been assessed by the authorities that those are similar and interchangeable. ICH Q4B工作组的目的是在ICH区域由法规当局对所有列在ICH Q6A指南中的检测方法达成互认。通过该指南，如果某方法经过当局评估为类似和可以互换，则不需要对不同药典的方法分别进行可比性测试。 The Annex 6 states that the following official texts : 附录6声明了以下官方文件 - Ph.Eur. 2.9.40 (Uniformity of Dosage Units
- 欧洲药典2.9.40（剂型均一性）
- JP 6.02 Uniformity of Dosage Units
- 日本药典6.02剂型均一性
- USP General Chapter <905> Uniformity of Dosage Units
- 美国药典通论<905>剂型均一性
can be used as interchangeable. Nevertheless, certain restrictions listed under the section "Analytical Procedures" have to be considered. 可以互换。当然，应用时要考虑“分析程序”项下的特定限制。 更多细节请参见完整FDA“Q4B-附录6剂型均一性通则”。 PS: At the QbD/PAT Conference from the University of Heidelberg from 15-16 October 2014, Dr ?yvind Holte from the Norwegian Medicines Agency will present the uniformity of dosage units using large sample sizes (Ph.Eur. 2.9.47). Dr ?yvind Holte is a member of both the EDQM PAT working party and the EMA PAT team. 另：在2014年10月15-16日在海德堡举办的QbB/PAT会议中，挪威药监局的?yvind Holte博士将会说明如何使用大样品量测试剂型均一性（欧洲药典2.9.47）。?yvind Holte博士是EDQM PAT工作组和EMA PAT组的成员。 | 
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发表于 2014-9-21 11:12:23
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