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【讨论】解读中国式医改 业内人士博弈政策重点走向

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【求助】如何查看WO的专利全文

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【讨论】海王金樽为什么会一败涂地

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  • yxx_168
    yxx_168  的帖子被加了1分 1天前

    QbD 学习讨论

    QbD感觉现在不热门了。其实,QbD无论对于审批者还是开发者,都是必要的。本人意欲弄一个专栏,供大家互相学习、互相探讨。不知大家觉得如何?
  • yxx_168
    yxx_168  发布了新帖 QbD 学习讨论 3天前

    QbD感觉现在不热门了。其实,QbD无论对于审批者还是开发者,都是必要的。本人意欲弄一个专栏,供大家互相学习、互相探讨。不知大家觉得如何?

  • yxx_168
    yxx_168  发布了新帖 Effective Contamination Control Strategy 75天前

    Developing an Effective Contamination Control Strategy Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting. Sep 02, 2019 By Siegfried Schmitt Pharmaceutical Technology Volume 43, Issue 9, pg 58, 57 Q. A recent

  • yxx_168
    yxx_168  发布了新帖 FDA Expands API Impurity 75天前

    FDA Expands Scope of API Impurity Investigation Aug 29, 2019 By Pharmaceutical Technology Editors FDA lowered its estimate of the impact on patients of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs while expanding its investigation to other types of drugs that may have been manufactured using processes that pose a risk for f

  • yxx_168
  • yxx_168
    yxx_168  发布了新帖 Pfizer Invests $500 Million into Gene 90天前

    Pfizer Invests $500 Million into Its Gene Therapy Facility Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC. Aug 21, 2019 By Pharmaceutical Technology Editors On Aug. 21, 2019, Pfizer announced that it is investing an additional half billion-dollars for the construction

  • yxx_168
    yxx_168  回复了帖子 新3类到底怎么做临床? 96天前
    BE+临床实在是花冤枉钱,提高国内企业仿制国外原研品的成本(当然最终也还是老百姓来买单)。要么BE,要么临床。100对临床算怎么回事么。
  • yxx_168
  • yxx_168
    yxx_168  回复了帖子 国内有上市,原研未在国内上市,算几类? 119天前
    谢谢回复!如果算3类,那么要进行临床实验,不只是BE了?
  • yxx_168
    yxx_168  发布了新帖 FDA Withdraws 31 ANDAs from Apotex 120天前

    FDA Withdraws Approval of 31 ANDAs from ApotexJul 17, 2019 By Pharmaceutical Technology EditorscGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAsIn July 2019, FDA published a note in the US Federal Register that it is withdrawing its prior approval of 31 abbreviated new drug applications (ANDAs) from Apotex, due to cGMP issues

  • yxx_168
    yxx_168  回复了帖子 国内有上市,原研未在国内上市,算几类? 120天前
    谢谢回复!如果这样不少的一致性评价产品,实际上都属于3类了?
  • yxx_168
    yxx_168  发布了新帖 国内有上市,原研未在国内上市,算几类? 121天前

    有一个产品,国内有上市产品(含原料与制剂),但是原研仍未在国内上市,是不是应该算四类?还是三类?

  • yxx_168
    yxx_168  回复了帖子 溶出曲线 125天前
    谢谢!该产品没有收入药典,只有一个进口标准。进口标准中就是SDS 4%。“能把不同批次参比曲线做到一致的溶出方法,才是最终的方法;”我们也一直在寻找这个介质。该产品还有一个最大的问题是,批内批间的溶出度曲线相关巨大,F2只有20左右。“通过药时曲线-吸收曲线-体内释放曲线来反向推导确认体外溶出曲线的终溶出度。”希望可以分享您的经验。如何做到?
  • yxx_168
    yxx_168  悬赏2丁当求助 127天前

    溶出曲线

  • yxx_168
    yxx_168  发布了新帖 FDA Releases Draft Guidance 127天前

    FDA Releases Draft Guidance on Population Pharmacokinetic AnalysisThe new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.Jul 11, 2019 By Pharmaceutical Technology EditorsFDA published draft guidance on July 11, 2019 for sponsors of new drug applications a

  • yxx_168
    yxx_168  发布了新帖 Industry Responds to UK Government 127天前

    Industry Responds to UK Government Planning for ‘No-Deal’ BrexitJun 28, 2019 By Pharmaceutical Technology EditorsThe Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have issued responses to the recently published governmental guidance on European Union exit preparedness.A letter from Steve O

  • yxx_168
    yxx_168  回复了帖子 工业药剂学的理论与实践 142天前
    感谢!感谢!非常感谢!!
  • yxx_168
  • yxx_168
    yxx_168  回复了帖子 儿科临证医案(2009高清版) 148天前
    您没有权限阅读该帖子
  • yxx_168
    yxx_168  回复了帖子 发几本书,无需丁当 148天前
    您没有权限阅读该帖子

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