The Parenteral Drug Association is offering the opportunity to preview documents produced by the European Federation of Pharmaceutical Industries and Associations at its Quality by Design workshop.
The EFPIA mock documents (case studies) mimic a hypothetical application and reflect what would be done for a biochemical, pharmaceutical and analytical development conducted under a QbD approach for a biotech API and an injectable product.
The work is being presented to PDA workshop delegates, prior to presentation to European health-policy makers from the European Medicines Agency (EMEA), in London on 28-29 September, 2009.
The documents' authors will seek input from workshop delegates on their presentations.
Brian Whithers, co-chair of EFPIA's Product Development and CMC ad hoc group, said: 'The purpose of these case studies is to provide some examples of how a S2 and P2 section, respectively, might look for a parenteral product developed using an enhanced QbD development approach, as envisaged in ICH Q8R.
'They are not intended to be all encompassing, and are not intended to represent the only way that development of a parenteral product can proceed, or be presented .
He added: 'They are intended to stimulate thought and discussion of the possibilities that ICH Q8, 9 and 10 present for potential products.'
