药物注册中的晶型问题？关于药物注册中涉及的晶型问题（可以包括某一药物晶型研究、粒度、稳定性有效性等与药品注册要求相关的问题 药物注册中涉及的晶型问题, if you can get API technique packages from suppliers, normally you can find the information you need from the package. If the supplier filed Drug Master File (DMF), you can use their DMF as your reference when you write your CMC section. You don't need do by yourself. If you are working on your New Chemical Entity (NCE), you need work on 晶型研究、粒度、稳定性. For crystal characterization, normally we use XPRD, NMR. For particle size, you can prepare dry sample or wet sample based on what kind of particle size you have. You can try laser diffraction method and confirm by image analysis such as microscopy, SEM. All the method validation, method, specification need write in your CMC section. 药物晶型、粒度 are related to drug dissolution release profile. Therefore it may affect 有效性. So you need charaterize your drug crystal form, set up spec for your particle size, check stability. All the results need have documents and write formal reports.查看更多
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