ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5

The S11 guideline is proposed to provide direction on the nonclinical safety studies important to support a paediatric development program. It will recommend standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provide 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.

Keywords: nonclinical safety, testing, paediatric medicines, weight of evidence approach


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