Application of ADaM in safety analysis of bioequivalence trail of generic drugs
10.12092/j.issn.1009-2501.2020.06.008
- VernacularTitle: ADaM在仿制药生物等效性试验安全性分析中的应用
- Author:
Tianyi ZHU
1
Author Information
1. School of Public Health, Nanjing Medical University
- Publication Type:Journal Article
- Keywords:
Analysis Data Model;
Bioequivalence trial;
Clinical Data Inter-change Standards Consortium
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(6):658-663
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To promote the Clinical Data Inter-change Standards Consortium (CDISC) standard in clinical trials and promote the standardization of clinical trial data. METHODS: To combine the implementation guide of Analysis Data Model (ADaM) and common problems of actual data, and to introduce the application of analytical data model ADaM in the safety of bioequivalence trails of generic drugs. RESULTS: For different types of clinical trial data, according to various situations that may occur, a safety analysis data set that meets the standards was generated. CONCLUSION: Under the background of the continuous development of generic drugs in China and the low degree of standardization of clinical trial data, the use of CDISC standards in clinical research can promote the standardization of clinical trial data, and can also shorten the time of statistical analysis and accelerate the process of drug development.
