生物技术领域的药典协调统一。
Pharmacopeial harmonization in biotechnology.
作者信息
Dabbah R, Grady L T
出版信息
Curr Opin Biotechnol. 1998 Jun;9(3):307-11. doi: 10.1016/s0958-1669(98)80065-7.
PMID:9687175
Abstract
There has been progress in the pharmacopeial harmonization initiative among the United States Pharmacopeia (USP), the European Pharmacopoeia and the Japanese Pharmacopoeia. Monographs on excipients and on biotechnology-derived products, as well as for General Chapters are progressing through the various stages of the harmonization process. An additional initiative, Concordance of Foreign Pharmacopeial Tests and Assays has been proposed by the USP.
摘要
美国药典（USP）、欧洲药典和日本药典之间的药典协调倡议取得了进展。辅料、生物技术衍生产品的各论以及通则各章正在协调过程的各个阶段推进。美国药典还提出了一项额外倡议，即《外国药典检验与分析一致性》。
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