注射劑一致性評(píng)價(jià)征求意見稿-資料下載頁(yè)
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【正文】 valuation and Research (CDER). Guidance for Industry: Changes to an Approved NDA or ANDA. April 2004Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers. May 20142USP 1202European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). EMA/CHMP/QWP/799402/2011: Reflection Paper on the Pharmaceutical Development of Intravenous Medicinal Products Containing Active Substances Solubilised in Micellar Systems. 2European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. January 20102Health Canada, Health Products and Food Branch. GUIDANCE FOR INDUSTRY: Pharmaceutical Quality of Aqueous Solutions. Febraury 20082Food and Drug Administration, Center for Drug Evaluation andResearch (CDER). Guidances（Drugs）：Generics:2Food and Drug Administration, Center for Drug Evaluation andResearch (CDER). Generic Drug Development: 2Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Generic Drugs. Filing Review of Abbreviated New Drug Applications, MAPP . September 2017. 2European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on Inuse Stability Testing of Human Medicine Products. September 2001.2European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicine Products. January 1998.為更好地服務(wù)申請(qǐng)人開展化學(xué)藥物注射劑一致性評(píng)價(jià)工作，總局一致性評(píng)價(jià)辦公室將組織對(duì)上述參考文獻(xiàn)進(jìn)行翻譯，及時(shí)在藥品審評(píng)中心網(wǎng)站公開。1. 若不給自己設(shè)限，則人生中就沒有限制你發(fā)揮的藩籬。2. 若不是心寬似海，哪有人生風(fēng)平浪靜。在紛雜的塵世里，為自己留下一片純靜的心靈空間，不管是潮起潮落，也不管是陰晴圓缺，你都可以免去浮躁，義無(wú)反顧，勇往直前，輕松自如地走好人生路上的每一步3. 花一些時(shí)間，總會(huì)看清一些事。用一些事情，總會(huì)看清一些人。有時(shí)候覺得自己像個(gè)神經(jīng)病。既糾結(jié)了自己，又打擾了別人。努力過(guò)后，才知道許多事情，堅(jiān)持堅(jiān)持，就過(guò)來(lái)了。4. 歲月是無(wú)情的，假如你丟給它的是一片空白，它還給你的也是一片空白。歲月是有情的，假如你奉獻(xiàn)給她的是一些色彩，它奉獻(xiàn)給你的也是一些色彩。你必須努力，當(dāng)有一天驀然回首時(shí)，你的回憶里才會(huì)多一些色彩斑斕，少一些蒼白無(wú)力。只有你自己才能把歲月描畫成一幅難以忘懷的人生畫卷。學(xué)習(xí)參考
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