New FDA - NIH Initiative on a Formulations Framework for paediatric Drugs

A collaborative initiative between the FDA and the NIH* is currently being developed to define a formulations framework for drugs that are used in pediatric patients.

This new FDA-NIH collaboration is looking at the developability of a lot of products with well accepted platforms. The idea then would be to group, classify and connect the APIs with feasible platforms for public information. This does also require an evaluation of existing platforms, identification and prioritization of the needs, physicochemical and stability evaluation, and pk simulations. The aim is to offer this information in a public domain, so that anyone with interest should be able to take it to further clinical and pharmaceutical development quickly without having to spend too many resources in the basic development work.

This new initiative and the physicochemical and pharmacokinetic considerations within the FDA-NIH Collaboration will be introduced by Dr Mansoor A. Khan, Director at the Division of Product Quality Research at FDA's CDER at the ECA Conference on Formulation Development & Manufacturing of Paediatric Drugs in Vienna, Austria, from 19-20 May 2010, which is part of ECA's Good Development Practice Conference.

*The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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