ICH S11 Nonclinical Paediatric Safety Guidelines


S11 Nonclinical Paediatric Safety

S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines

The S11 Guideline provides direction on the nonclinical safety studies important to support a paediatric development programme. It recommends standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides guidance on the design of the studies.

A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals will be achieved with the implementation of this new harmonised ICH Guideline.

Date of Step 4: 14 April 2020

Status: Step 5

Guidelines (Click the links below for complete guidelines)

S11 Final Guidelines

Endorsed Documents (Click the links below for complete guidelines)

S11 Concept Paper

S11 Business Plan

WG Presentations/Trainings (Click the links below for complete guidelines)

S11 Step 2 Presentation

S11 Step 4 Presentation

*These Guidelines Belongs to ICH website.

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