Nonclinical Safety Testing Guideline S11

 In Legislative change

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) issued the first draft of guideline S11 on Nonclinical Safety Testing in Support of Development of Pediatric Medicines in September 2018. The S11 Guideline is proposed to provide direction on the nonclinical safety studies important to support a pediatric 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.


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