Science-led regulatory strategies in nonclinical development of new medicines

被引：1

作者：

Roberts, Ruth ^{[1
]}

Jones, David ^{[1
]}

机构：

[1] ApconiX, Alderley Pk, Macclesfield SK10 4TG, England

来源：

TOXICOLOGY RESEARCH | 2023年

关键词：

Drug Discovery; Drug Development; Regulatory Guidelines; Decision making;

D O I：

10.1093/toxres/tfad017

中图分类号：

R99 [毒物学（毒理学）];

学科分类号：

100405 ;

摘要：

The development of a pharmaceutical is a stepwise process involving an evaluation of both animal and human efficacy and safety information. Regulations around drug development exist to protect people and the environment from harm and should create a level playing field for business, allowing well-run companies to thrive. However, adherence to good science should guide decisions rather than rigorously following guidelines, and there is almost always more than one way to get to the ultimate goal.

引用

页码：145 / 149

页数：5

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