Points to Consider for a P2

The Points to Consider for a P2 for an Orally Inhaled or Nasal Drug Product was developed by the IPAC-RS Model OINDP Working Group to provide industry perspectives and best thinking on the reporting of development data in the P2 (Pharmaceutical Development) section of the Common Technical Document.  The document follows the guidance provided in ICH Q8 but provides further insight on issues of significance for OINDP such as container closure systems/device and particle size.   The Points to Consider is a "living document,"  and IPAC-RS welcomes comments on the paper and feedback from its application.  Individuals at the FDA Office of New Drug Quality Assessment have reviewed the document and provided constructive comments, which have been incorporated.


The IPAC-RS Model OINDP Working Group's objective is to consider how ICH Quality guidelines, e.g. Q8, 9, 10, in conjunction with efficacy guidelines/paradigms can be applied generally to OINDP.  Throughout 2006 and 2007, the Working Group developed the Points to Consider to aid industry in its application of quality by design/ICH concepts.

Please send your comments on the Points to Consider to IPAC-RS at: IPAC-RS