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A new United States Pharmacopeia (USP) Chapter 1046: Cell and Gene Therapy Products
Cytotherapy ( IF 4.5 ) Pub Date : 2000-01-01 , DOI: 10.1080/146532400539044
S Seaver 1
Affiliation  

The United States Pharmacopeia (USP) has published the first draft of a new information chapter on cell and gene therapy products in January, 2000. The chapter discusses the manufacturing and testing cell and gene therapy products. It is intended for people working in the field as well as for pharmacists and clinicians who would like more information on this subject. This article outlines the background of USP and explains how it became involved with cell and gene therapy and what an information chapter is. It details the subjects covered by the chapter and the philosophy behind the chapter. This draft will be revised based on comments received from the public and then published as a revision subject to further comments before it becomes an official chapter in a supplement to USP 24-NF 19.

中文翻译:

新的美国药典 (USP) 第 1046 章:细胞和基因治疗产品

美国药典 (USP) 于 2000 年 1 月出版了关于细胞和基因治疗产品的新信息章节的初稿。该章节讨论了细胞和基因治疗产品的制造和测试。它适用于在该领域工作的人员以及希望获得有关该主题更多信息的药剂师和临床医生。本文概述了 USP 的背景,并解释了它如何参与细胞和基因治疗以及什么是信息章节。它详细介绍了本章涵盖的主题和本章背后的哲学。该草案将根据从公众收到的评论进行修订,然后作为修订版发布,并接受进一步的评论,然后成为 USP 24-NF 19 补充文件中的正式章节。
更新日期:2000-01-01
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