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Register... or knowledge of non-linearity [Regulatives / Guidelines]
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]
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 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- ... or knowledge of non-linearity Ohlbe 2012-01-31 17:47
- linear PK required for biowaiver Helmut 2012-01-31 02:45
Ing. Helmut Schütz