International – ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs

The purpose of this document is to recommend international standards for, and promote
harmonisation of, the nonclinical safety assessments to support the development of
pharmaceuticals intended for paediatric use. Harmonisation of the guidance for nonclinical
safety studies will define the current recommendations and reduce the likelihood that
substantial differences will exist among regions. It should facilitate the timely conduct of
paediatric clinical trials and reduce the use of animals in accordance with the 3R
(replace/reduce/refine) principles…