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... or knowledge of non-linearity [Regulatives / Guidelines]

posted by kudra23 – 2012-01-31 19:18 (5262 d 08:50 ago) – Posting: # 8032
Views: 2,489

Dear Helmut thanks for your prompt reply however, i exactly wanted to confirm what Ohlbe indicated. There are exceptions for non-linearity cases as per the new BE guideline (CPMP/QWP/EWP/1401/98 Rev. 1/Corr). In the previous version, non-linearity used to lead us to conduct BE study for all strengths.

Thank you both of you for your kind help. Regards,

Edit: unneeded quotation marks deleted [Ohlbe]

Complete thread:

unknown linearity kudra23 2012-01-30 10:30
- linear PK required for biowaiver Helmut 2012-01-31 02:45
  - ... or knowledge of non-linearity Ohlbe 2012-01-31 17:47
    - ... or knowledge of non-linearitykudra23 2012-01-31 18:18

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