Europe – ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals : Step 5

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…