The role of "go no-go" decisions in TB vaccine development

被引：6

作者：

Sadoff, JC ^{[1
]}

Hone, D ^{[1
]}

机构：

[1] Aeras Global TB Vaccine Fdn, Bethesda, MD 20814 USA

来源：

MICROBES AND INFECTION | 2005年 / 7卷 / 5-6期

关键词：

tuberculosis; TB vaccines; product development plan; product profile;

D O I：

10.1016/j.micinf.2005.03.015

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Go no-go decisions play a critical role in the product development plan of any TB vaccine at several points. Go no-go decisions are designed to serve the fundamental maxim in vaccine development that killing a bad vaccine project as early as possible is the hallmark of a successful overall program; in development, unlike in basic research, costs and skilled manpower requirements rise exponentially as the program proceeds. The opportunity costs in resources, manpower and equipment utilized on bad vaccine projects are unavailable to other vaccine programs. The go no-go decision is a fundamental piece of the process that balances risk, time and resources. An example of a go no-go decision development program is presented. (c) 2005 Elsevier SAS. All rights reserved.

引用

页码：899 / 904

页数：6