PDF《Zhigang Sun》

2019/5/20 药事纵横 https://mp.

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chksm=ecaa8bd… 1/12 粒度控制不明白的看过来,FDA专家把要点给你归纳好了! 引言 ⊙ 口服固体制剂生产中的物料为何需要制定粒度标准? ⊙ 粉末直压、湿法、干法、微丸生产的过程产品粒度分布如何考虑? ⊙ 粒度标准如何建立才能达到控制产品质量的一致性? ⊙ 粒度方法学验证与常规方法验证的区别是什么? ⊙ 如何科学制定粒度的可接受标准? 带着上述疑问,让我们一同走进由多位FDA审评专家撰写的文章Particle Size Specifications for Solid Oral Dosage Forms: A Regulatory Perspective,本文将给出全面的解析,值得一读!值 得收藏! 作者简介

1 Zhigang Sun Zhigang Sun is a Review Chemist in the Division of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. Before joining FDA in 2006, he worked as a senior development scientist at Malvern Instruments Inc. Zhigang received his Ph.D. in Chemical Engineering from Purdue University in

2001 and he has authored orco-authored over

20 journal articles, patents, and book chapter. Readers may contact the author directly t hi @fd hh 多巴胺 今天 药事纵横 2019/5/20 药事纵横 https://mp.weixin.qq.com/s?__biz=MzI5ODI5NDE2OA==&

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chksm=ecaa8bd… 2/12 at: [email protected]

2 Naiqi Ya Naiqi Ya is a Team Leader in the Divison of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. In his current capacity, he is responsible for reviewing chemistry and manufacturing control sections of new drug applications (ANDA/IND/NDA). Prior to joining FDA in 1996, he held a position at Biocraft Laboratories, Inc.,where his responsibilities included developing and validating analytical methods for drug substances and drug products. He received his Ph.D. in Bioanalytical and Biophysical Chemistry from New York University in 1994.

3 RichardC. Adams Richard C. Adams is the Deputy Director in theDivision of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. He joined FDA'

s Office of Generic Drugs in

1990 as a review chemist and later became Branch Supervisor, and Deputy Division Director. He has served on numerous office and center technical committees and ad hoc working groups and has chaired the Center Stability Technical Committee. Prior to joining CDER, he worked with Pfizer, Inc. at their Central Research Facility in Groton, CT, having responsibilities as a Senior Research Scientist and Project Leader in Process Research and Development. Richard holds a B.S. in Chemistry from the University of Maine and an M.B.A. from the University of New Haven.

4 Florence Fang Florence Fang is the Director in the Division of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. She has been involved with the chemistry review function for abbreviated new drug applications for twenty years. Prior to the regulatory work at the Food and drug Administration, she was with Alza in the development of biodegradable polymers and drug delivery systems. She also worked at Gillette Research Institute in keratin chemistry. She holds a B.S. in Chemistry from Purdue University and a M.S. in Biochemistry from the University of 2019/5/20 药事纵横 https://mp.weixin.qq.com/s?__biz=MzI5ODI5NDE2OA==&