Representative batches? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-08-05 14:45 (4954 d 21:44 ago) – Posting: # 5726
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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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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