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CTD申报资料中杂质研究的几个问题 - 医药信息 - TransTo 医药信息 健康百科
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CTD Common Technical Document 申报格式体现了过程控制和终点控制相结合、研究和验证相结合、全面系统的药品质量控制理念，更加符合杂质研究与控制的基本规律和逻辑思路。 如制剂的原辅料控制中，原辅料的选择与控制要考虑以符合制剂质量要求 杂质等 为核心，必要时进行精制处理并制定内控标准 关键工艺步骤及参数的确立、工艺开发过程等要考虑以杂质是否得到有效控制为重点关注之一 制剂相关特性中要体现与原研产品杂质谱等的对比情况 包材、贮藏条件以及有效期的确立等也要以杂质是否处于安全合理的可控范围内为核心等等。 如详细的杂质研究报告可以体现在3.2.S.4.5中 3.2.S.3.2要报告杂质研究的结果 杂质分析方法的筛选、研究与验证内容要在3.2.S.4.3中体现 对仿制药而言，杂质限度确定的论证与依据需要在与原研产品进行全面的杂质谱对比研究基础上进行论证说明，因此，与原研产品的对比研究及结论要在3.2.S.4.5中体现。 基于杂质谱分析的杂质研究是一种 以源为始 的主动思维模式，以 质量源于设计 的观点，从杂质来源入手，从制备工艺、化学结构、处方组成的分析出发，评估、预测产品中可能存在的及潜在...
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国家食品药品监督管理总局发布《创新医疗器械特别审批... - 医药信息 - TransTo 医药信息 健康百科
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国家食品药品监督管理总局发布 创新医疗器械特别审批. . 本帖最后由 pharmer 于 2014-2-11 10:38 编辑. 2014年2月7日，国家食品药品监督管理总局发布了 创新医疗器械特别审批程序 试行 食药监械管 2014 13号 ，自2014年3月1日起施行。 GMT 8, 2016-8-24 07:31 , Processed in 0.401033 second(s), 24 queries .
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transtlanticism.deviantart.com
Transtlanticism (Eilidh) - DeviantArt
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营销 史上最全的100个创意促销方案了 微营销活动必备 . 营销 史上最全的100个创意促销方案了 微营销活动必备 请收藏 分享自微信 DoHel. Discuz 3 触屏版 如何更换logo. 了解详情，请到 www.transto.com. GMT 8, 2015-8-15 05:39 , Processed in 0.054336 second(s), 13 queries .
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Better transportation for all Torontonians. To LRT, or Not To LRT? 8230; Subway is the Answer. June 24, 2015. June 24, 2015. After researching and analyzing most LRT systems in the world, we conclude that when placed at street level, they end up being a complete waste of money, space, and other resources, which can otherwise be used in more efficient and effective transit systems like subways or express buses. Examples of development over Toronto subway stations. All residents and businesses along Finch ...
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This application is intended to facilitate the transliteration or transcription of a word or a text from the Roman script into the Toba Batak script. Transliterating from the Roman into the Batak script is not an easy undertaking as the Batak script has a number of peculiarities that complicates the process of transliteration. This program uses a set of algorithms which enables the user to effortless transliterate from the Roman to the Toba Batak script. Uli (@) bahasa.net. And transtoba2 (@) manducus...
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