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本帖最后由 巴西木 于 2014-4-13 17:30 编辑
翻译人：Julia
D. Amendments to Pending ANDA Application 未批准ANDA申请的增补 Q1: What are the recommendations for amendments and responses filed to pending ANDAs after issuance of the new guidance? 在新指南发布后，如何处理尚未批准的ANDA所需的增补和回复？ A1: All amendments submitted to pending ANDAs after the effective date of the final stability guidance will be held to the standards in place at the time of the original ANDA submission, unless there is a concern with the submitted stability data. 在稳定性指南正式生效后，所有对未批准ANDA所提交的增补均按初始ANDA提交时的标准要求处理，除非其中涉及已提交的稳定性数据。 E. Stability Studies 稳定性研究 Q1: What will be the expected testing time points on accelerated conditions? 加速条件下试验时间点要求是怎样的？ A1: In general, we recommend four time points (i.e., 0 (initial release), 3 months, 6 months, and one additional time point) to the study design for all ANDAs[1]. 一般来说，我们推荐对所有ANDA研究设计均使用4个时间点（即0点（初始检验放行）、3个月、6个月和1个附加时间点）。 Q2: Can the Agency clarify expectations for the storage positions for products placed into the stability program? 官方是否可以澄清一下对放入稳定性试验程序的产品的存贮位置有什么要求？ A2: For primary batches of liquids, solutions, semi-solids, and suspensions, the product should be placed into both inverted (or horizontal) position and upright (or vertical) position. For routine stability studies, the firm should pick the worst case orientation for the study. 对于液体、溶液、半固体和混悬剂的初始批次，产品应采用垂直和水平两种状态放置。对于常规稳定性研究，公司应选取最差情况进行研究。 Q3: When and how are reconstitution/dilution studies performed? 什么时间需要进行溶解/稀释研究？如何进行？ A3: Recommendations listed in Q1A(R2), section II, B, 7, Storage Conditions (2.2.7) should be followed for all three batches. These studies should be performed when the drug product is labeled for reconstitution or dilution. 在Q1A(R2)第II部分，B.7中，存贮条件（2.2.7）中给出了推荐意见，所有3批均应按该要求进行。如果产品标示需要溶解或稀释，则需要进行这些研究。 Q4: What type of containers are classified as semipermeable containers, and can the Agency clarify the stability expectations for the drug products in semipermeable containers? 什么类型的包装归类为半透包装，官方是否可以对半透包装的稳定性要求进行说明？ A4: Examples of semipermeable containers are provided in the Q1A(R2) glossary. The recommendations for stability expectations for semipermeable containers are detailed in ICH Q1A(R2) section II, B, 7, c. Drug products packaged in semipermeable containers (2.2.7.3). 在Q1A(R2)术语中已提供了半透包装的举例。对半透包装的稳定性要求在ICH Q1A(R2)第II部分，B.7.c.“半透包装药品”（2.2.7.3）中有详细说明。 Q5: Can the Agency clarify expectations around the number of batches to support tests such as preservative effectiveness and extractable leachable testing? 官方可否说明一下支持象具代表性有效性和溶出试验这样的支持性测试所需要的批次数是多少？ A5: One of the primary batches of the drug product should be tested for antimicrobial preservative effectiveness (in addition to preservative content) at the end of the proposed expiration dating period. The drug product specification should include a test for preservative content, and this attribute should be tested in all stability studies. 初始批次中的1批应进行在申报的有效期结束时测试抗微生物防腐效果（除防腐剂本身外）。药品质量标准应包括防腐成份检测，该属性应在包括在所有稳定性试验中。 Extraction/leachable studies are generally one time studies; however, if multiple types of containers/closures are employed for packaging, then additional studies could be recommended. 溶出物/浸出物研究一般是一次性研究，但是，如果采用了不同容器/密闭系统进行包装，则推荐进行更多研究。
Q6: When are in-use stability studies needed? 什么时候需要进行在用稳定性试验？ A6: Please refer to response A3 under section E Stability Studies. 请参见E稳定性研究部分对A3的答复。
Q7: Are there changes to postapproval protocols and commitments when ICH stability guidances are implemented because of scale or type of batches submitted? 在ICH稳定性指南实施后，会不会因为提交的批次批量或类型原因而需要对已批准稳定性方案和承诺进行变更？ A7: ICH Q1A(R2), section II, B, 8, Stability Commitment (2.2.8) addresses this question. Section 2.1.8 provides information regarding stability commitment for drug substances. ICH Q1A(R2), 第II部分, B, 8, 稳定性试验承诺(2.2.8)对此问题进行了说明。在2.1.8部分说明了关于制剂产品稳定性承诺相关的信息。
[1] This recommendation also applies to nasal spray, inhalation solution, suspension, aerosols, and liposomal drug products.
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发表于 2014-4-13 17:25:23
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