Representative batches? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-08-05 12:45  – Posting: # 5726
Views: 10,164

Dear Dan!

» But can you argue with the assessor without statistics?

Statistics – A subject which most statisticians find difficult
but in which nearly all physicians are expert.
Stephen Senn

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.
Stephen Senn; Statistical Issues in Drug Development. Wiley, p386, 2004


» As other sponsors we selected T & R batches which matched closely. Comparative dissolution profiles showed similarity and the assay content differed less than 5%.
» From the quality point of view we see no difference between the batches.

Yes, everybody did/does it that way (see also the last paragraph in ElMaestro’s post). Of course that's not representative, but 'best'.

» The logic consequence would be that for the release of any batch you produce for the market you have to perform a BE study as quality control.

Yes, but would be applicable to the innovator as well. I would remind the assessor that this idea was already abandoned 15+ years ago and on the consequences.

Cheers,
Helmut Schütz
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