The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
This new ICH Guideline is proposed for harmonisation of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and therefore improve the speed of access to new drugs for paediatric patients while limiting the number of children required for enrolment in clinical trials.