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Registertruncated design [Regulatives / Guidelines]
Dear All,
For truncated design (AUC truncated to 72 hours) is it required to take additional samples 72.00 hrs onwards to identified intra subject variability of AUC0-∞ or regulatory agency accept PK data up to 72.00 hrs.?
Regards
For truncated design (AUC truncated to 72 hours) is it required to take additional samples 72.00 hrs onwards to identified intra subject variability of AUC0-∞ or regulatory agency accept PK data up to 72.00 hrs.?
Regards
Complete thread:
- truncated designMahesh M 2015-12-29 11:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: AUC0–72 Helmut 2015-12-29 13:12
- FDA: AUC0–72 Mahesh M 2015-12-29 13:51
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: crystal ball Averroes 2016-05-27 00:01
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: AUC0–72 Mahesh M 2015-12-29 13:51
- FDA: AUC0–72 Helmut 2015-12-29 13:12
Ing. Helmut Schütz