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Dear Helmut and Karthik,
On a PK and BE point of view, I would say the global CV has no value at all.
But I've heard some regulators say that they have seen studies with a global CV which was surprisingly low (10 %, for AUC and Cmax). When inspected, the studies turned out to be totally invented, falsified... So on a regulatory point of view, the global CV and its comparison with other trials (including literature data) may provide some other level of information...
Regards
Ohlbe
❝ ❝ its possible to compare our study report with reference literature?
❝
❝ Sure, but of limited value.
On a PK and BE point of view, I would say the global CV has no value at all.
But I've heard some regulators say that they have seen studies with a global CV which was surprisingly low (10 %, for AUC and Cmax). When inspected, the studies turned out to be totally invented, falsified... So on a regulatory point of view, the global CV and its comparison with other trials (including literature data) may provide some other level of information...
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- WHO BTIF K2K 2012-01-12 05:15 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WHO BTIF Helmut 2012-01-12 13:55
- WHO BTIF K2K 2012-01-13 05:51
- WHO BTIF Helmut 2012-01-13 17:05
- WHO BTIFOhlbe 2012-01-13 18:41
- WHO BTIF Helmut 2012-01-13 18:54
- WHO BTIF K2K 2012-01-16 12:51
- Inter- or intra-subject CV? Helmut 2012-01-16 13:26
- intrasubject K2K 2012-01-16 13:35
- intrasubject Helmut 2012-01-16 14:50
- intrasubject K2K 2012-01-18 09:36
- intrasubject Helmut 2012-01-16 14:50
- intrasubject K2K 2012-01-16 13:35
- Inter- or intra-subject CV? Helmut 2012-01-16 13:26
- WHO BTIF K2K 2012-01-16 12:51
- WHO BTIF Helmut 2012-01-13 18:54
- WHO BTIFOhlbe 2012-01-13 18:41
- WHO BTIF Helmut 2012-01-13 17:05
- WHO BTIF K2K 2012-01-13 05:51
- WHO BTIF Helmut 2012-01-12 13:55
Ing. Helmut Schütz