Development is a subject on which the supervisory authorities have
increasingly focused in recent years. In this context, an old/new
technique, Design of Experiments (DoE), is mentioned time and again.
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.
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