Bioequivalence and Bioavailability Forum

off-topic [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2010-10-20 19:39 (5729 d 05:33 ago) – Posting: # 6067
Views: 4,244

Dear D. Labes!

❝ ❝ […] the Munich conference is approaching …

❝

❝ Helmut: Good luck for that.

THX; I’m especially interested in the roundtable discussion on day two lead by Kersti Oselin (MHRA):

Investigating Outlier Checks and their Role in Establishing Bioequivalence

In London (June this year) she essentially said that PK outliers (e.g., due to mixed-up samples) can’t be removed – even if keeping them would lead to BE of a generic, which would fail otherwise.*
This was one of the reasons I stated there “The EMA is a serious risk to public health!”

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• Gerald Beuerle’s example:
  

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


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Science Quotes

Complete thread:

• two-stage design according the new draft of the emea helena colom 2010-10-18 14:40 
  • Two-stage design questions d_labes 2010-10-20 09:47
    • StudySize Helmut 2010-10-20 14:12
      • StudySize - Monte carlo d_labes 2010-10-20 17:13
        • off-topicHelmut 2010-10-20 17:39
        • StudySize - Monte carlo helena colom 2010-10-21 23:23
  • two-stage design according the new draft of the emea AngusMcLean 2010-11-03 16:20