Introduction of good documentation practice for model based drug development
10.13699/j.cnki.1001-6821.2017.20.025
- VernacularTitle:基于模型药物研发文档规范的介绍
- Author:
Yan-Fei LI
1
;
Lu-Jin LI
;
Kun WANG
;
Qing-Shan ZHENG
;
Ling XU
Author Information
1. 上海中医药大学药物临床研究中心
- Keywords:
model based drug development;
pharmacometrics;
documentation;
specification
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(20):2084-2088
- CountryChina
- Language:Chinese
-
Abstract:
Pharmacometrics is a useful tool,and its application in drug discovery and development has been approved and supported by relevant regulatory agencies.In 2004,the food and drug administration (FDA) issued Inovation or Stagnation:Challenges and Opportunity on the Critical Path to New Medical Products,and it addressed that systematic application of the concept of Model Based Drug Development (MBDD) had the potential to significantly improve drug development.Many guidelines of China food and drug administration (CFDA) recommended the use of MBDD.Specification documentation will guarantee the quality of MBDD results and the high-efficiency of regulatory review.However,there is no unified standard for domestic MBDD documentation specification in China.Based on the white paper of European Federation of Pharmaceutical Industries and Associations (EFPIA),and combined with guidelines of FDA and European Medicines Agency(EMA),this paper put forward some reasonable suggestions on good documentation practice for MBDD to enhance MBDD application in drug development and regulatory assessment,and would be a valuable reference for the industry standards in the future.
