Considerations on the repeated bioequivalence studies in control of the type I error
10.13699/j.cnki.1001-6821.2019.08.024
- VernacularTitle:重复生物等效性试验中Ⅰ类错误控制方面的考虑
- Author:
Min-Ji WEI
1
;
Hong CUI
;
Pu ZHANG
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
bioequivalence;
repeated bioequivalence test;
type Ⅰ error;
depletion of α value
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(8):808-811
- CountryChina
- Language:Chinese
-
Abstract:
In the bioequivalence (BE) studies,repeated BE tests are often encountered due to many reasons. How to carry out such kind of tests,currently,no guideline could be referenced. Based on the two - stage design,α spending (type Ⅰ error) was investigated in the repeated bioequivalence studies under various situations,and example was given for demonstration purpose. It is expected type Ⅰ error be kept under the regulatory requirements by means of adoption of different α values during the repeated BE tests.
