No chance against RMS? [Regulatives / Guidelines]

posted by Dr_Dan  – 2010-08-10 12:27  – Posting: # 5759
Views: 9,961

Dear all,
First of all thank you very much for your invaluable input which I summarize in the following:
  1. BE studies are not suitable to assess inter-batch variability. Batch is never a factor in ANOVAs according to recommendations published by the Efficacy Working Party
  2. A batch to batch variation is a module 3 issue. The assessment of module 3 revealed no difference between test and reference batches. Comparative dissolution profiles showed similarity and the assay content differed less than 5%.
  3. It's a common property of HVDs that not only the variance is high, but also the location of the T/R-ratio may vary across studies. There is no regulatory criterion requesting that the point estimators between BE studies must not varying.
  4. There were also differences in the batch number of the reference product and thus the difference in point estimates cannot be attributed a priori to the test product alone.
  5. None of the four studies demonstrated bioINequivalence. With increased sample sizes the studies would all be expected to be acceptable.
This was the first part of my problem...

The second is: To be right is one thing, that the assessor admits that we are right is the other thing.
My experience with this assessor is that he does not want to revise his opinion and he will not care about our arguments.

This assessor represents the view of the RMS (Germany). Even if one, two or all CMS disagree the procedure will come at an end and we will not get a marketing authorization (please correct me if I am wrong). A referral will not take place, so we do not have the possibility to argue against this assessor opinion in front of an expert committee.
What shall we do?
I am looking forward to your replies.
Kind regards
Dan

P.s.: Dear Helmut, please change the category to regulatory, thanks!


Done. [Helmut]

Kind regards and have a nice day
Dr_Dan

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