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RegisterFDA on Truncated AUC [Regulatives / Guidelines]
Hi guys,
Question.. Can I use truncated AUC if the drug has an average half-life of 25-30 hours? The upper range can be as high as 60 hours but my 6 subjects in a pilot all have t1/2 no greater than 27 hours. If I go without truncated AUC then i will probably have to sample out to 120-144 hours. The AUCt/AUCinf ratio on average (n=6) is 90%.
Thanks
John
Question.. Can I use truncated AUC if the drug has an average half-life of 25-30 hours? The upper range can be as high as 60 hours but my 6 subjects in a pilot all have t1/2 no greater than 27 hours. If I go without truncated AUC then i will probably have to sample out to 120-144 hours. The AUCt/AUCinf ratio on average (n=6) is 90%.
Thanks
John
Complete thread:
- FDA on Truncated AUCjag009 2012-07-25 16:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA on Truncated AUC Helmut 2012-07-25 17:01
- FDA on Truncated AUC jag009 2012-07-25 17:19
- FDA on Truncated AUC Helmut 2012-07-25 17:28
- FDA on Truncated AUC jag009 2012-07-25 17:19
- FDA on Truncated AUC Helmut 2012-07-25 17:01
Ing. Helmut Schütz