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Solid form changes during drug development: good, bad, and ugly case studies
AAPS Open Pub Date : 2016-02-25 , DOI: 10.1186/s41120-016-0003-4
Ann Newman , Robert Wenslow

The relevance of solid form in drug development has been well established over time. In order to fully understand drug properties, attention has been paid to solid state structure of drug molecules and their relationship to the drug formulation. While each drug developer has had their own strategies and workflows for screening and choosing solid forms of drug molecules, the industry is aware of instances where “the best laid plans” often go awry. This manuscript has summarized several case studies in development programs that display the “good, bad, and ugly” of solid form changes.

中文翻译:

药物开发过程中的固体形式变化:好的,坏的和丑陋的案例研究

随着时间的流逝,固体形式在药物开发中的重要性已经得到了很好的确立。为了充分理解药物性质,已经关注药物分子的固态结构及其与药物制剂的关系。尽管每个药物开发人员都有自己的筛选和选择固体分子形式的策略和工作流程,但业界知道“最佳计划”常常出问题的情况。该手稿总结了开发程序中的几个案例研究,这些案例研究显示了实体形式更改的“好,坏和丑陋”。
更新日期:2016-02-25
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