Guidance published on pediatric medicine development

New  draft guidance has recommended international standards for the use of non-clinical safety studies to support the development of pediatric medicines.

The draft was prepared at the behest of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), a body whose guidelines are published by the US Food and Drug Administration as guidances.

The ICH is asking for comments on the draft, which provides a weight of evidence approach to determine when non-clinical toxicity studies may be recommended in juvenile animals. If such research is advised, the guidance provides appropriate study designs.