DoE from the Authorities' Point of View

EMEA's PAT Team has published a Reflection Paper describing preliminary recommendations on the presentation of PAT-relevant information in applications or variation applications for a marketing authorisation.

Apart from Quality Risk Management (see our GMP News of 9 May 2006), another focus is on the topic of DoE.

DoE is considered to be a help tool both in the development of the formulation and in process development. If DoE is applied, EMEA wants to receive a description of the experiments and an - if possible - graphical representation with a descriptive interpretation. It is pointed out that the applicant should provide the assessor with "adequate levels of information" so that the assessor can understand what was examined and why. Of course, the authority also expects the right conclusions to be drawn. Then, the paper gives a detailed list of items that could be relevant to the marketing authorisation. This list mentions among others the indication of the type of experimental design (full/factorial design), but also graphical representations, statistical evaluations and, naturally, the design space. A verification of the model based on DoE is another item. The document mentions expressly that different information levels are possible depending on the developmental stage (early or late phases).

The fact that DoE can speed up an application for a marketing authorisation is set out in a GMP News of 27 April 2006 with an example of Genentech applying for a US marketing authorisation.
  

 
Author:
Sven Pommeranz
On behalf of ECA

The complete text of EMEA's Reflection Paper can be found here.