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RegisterAUCt > 80% AUCinf (EU) [Regulatives / Guidelines]
Dear Ravi!
Please do your homework first: FDA, EMEA.
BTW, for IR formulations any sampling after 72 hours most likely will be dropped in the next revision of the European guidline in accordance with the WHO:
'It is currently not foreseen that there would be a need for blood samples to be collected for more than 72 hours.'
❝ What is the criteria given in any of the regularity guidlines (USFDA, EMEA).
Please do your homework first: FDA, EMEA.
BTW, for IR formulations any sampling after 72 hours most likely will be dropped in the next revision of the European guidline in accordance with the WHO:
'It is currently not foreseen that there would be a need for blood samples to be collected for more than 72 hours.'
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Regards, Jaime
Regards, Jaime
Complete thread:
- Ratio of AUCt to AUCinf Ravi 2008-06-13 13:27 [Regulatives / Guidelines]
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- AUCt > 80% AUCinf (EU)Jaime_R 2008-06-13 15:14
Ing. Helmut Schütz