美国关于总体和个体生物等效性方法的指导草案：一家研发型制药公司的评论
The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company.
作者信息
Hauschke D, Steinijans V W
机构信息
Department of Biometry, Byk Gulden Pharmaceuticals, Byk-Gulden-Str. 2, 78467 Konstanz, Germany.
出版信息
Stat Med. 2000 Oct 30;19(20):2769-74. doi: 10.1002/1097-0258(20001030)19:20<2769::aid-sim544>3.0.co;2-8.
Abstract
Generally, the motivation for switching from average bioequivalence to population and/or individual bio-equivalence is well recognized in the light of certain limitations of the concept of average bioequivalence. However, this switch still results in unresolved issues which should be addressed before the regulatory guidance is finalized.
摘要
一般来说，鉴于平均生物等效性概念的某些局限性，从平均生物等效性转向群体和/或个体生物等效性的动机已得到充分认可。然而，这种转变仍然导致了一些未解决的问题，在监管指南最终确定之前，这些问题应该得到解决。
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