Seltzer Jonathan H, Li Judy, Wang William
1 ACI Clinical, Bala Cynwyd, PA, USA.
2 Biostatistics, Celgene Corporation, San Diego, CA, USA.
Ther Innov Regul Sci. 2019 Mar 29:2168479018793130. doi: 10.1177/2168479018793130.
The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section.
美国统计协会和药物信息协会组建了一个跨学科工作组,其成员包括来自学术界、行业界和监管部门的药物安全专家,旨在探索安全监测的未来方向。本系列文章的引言部分阐述了此专题的背景和基本原理。