对《中国药典》(2015版)中1431生物检定法的六点探讨  

Discussion on general chapters 1431 in the Chinese Pharmacopoeia 2015

作　　者：卢志兵 LU Zhibing(Longyan Center for Food and Drug Control,Longyan 364000,China)

机构地区：[1]龙岩市食品药品检验检测中心,龙岩364000

出　　处：《中国药品标准》2021年第2期110-112,共3页Drug Standards of China

摘　　要：生物检定统计法是《中国药典》生物检定的内容之一,涉及到数理统计领域。本文对《中国药典》2015年版生物检定法中概念模糊、所列举例中可商榷之处提出探讨,旨在保证《中国药典》的科学性、先进性和规范性,提升它的权威性。Objective:The bioassay statistics method belongs to a part of the contents in bioassay of the Chinese Pharmacopoeia 2015,and involves mathematical statistics.The discussion on the ambiguity in bioassay method of the Chinese Pharmacopoeia 2015 is made.That aims to ensure the scientific,advance and normal of the Chinese Pharmacopoeia and to enhance its authority.

关 键 词：中国药典 生物检定法 

分 类 号：R921.2[医药卫生—药学]