Log in
Register0 hr Pre-dose concentration but less than 5% of Cmax [Regulatives / Guidelines]
Thanks Helmut
That's what I thought as well (Keeping the subject) since the guidance just stated the 5% rule but nothing about period 1 or period n.
John
❝ Shit happens. But:
- The guidance does not distinguish between period 1 and the others. Though you are right that pre-dose values in period 1 are less likely (carry-over due to too short wash-out are possible in higher ones).
❝
- If you have an SOP for pharmacokinetic repeats in place perform a reanalysis. Maybe the value will not be confirmed.
❝
- Remember the requirements for testing interferences in method validation: none out of six independent sources of matrix. If 0/6 is OK does that imply that 1/7 is OK as well? In other words even if your method was validated – in a large study you may see interferences. Keep the subject.
That's what I thought as well (Keeping the subject) since the guidance just stated the 5% rule but nothing about period 1 or period n.
John
Complete thread:
- 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50
- 0 hr Pre-dose concentration but less than 5% of Cmaxjag009 2012-03-29 20:10
- Reanalysis if possible Helmut 2012-03-29 23:17
- Reanalysis if possible jag009 2012-03-30 15:06
- >6 sources of matrix Helmut 2012-03-30 15:16
- >6 sources of matrix jag009 2012-03-30 20:40
- >6 sources of matrix Helmut 2012-03-31 00:23
- >6 sources of matrix jag009 2012-04-04 16:32
- Flashback Helmut 2012-04-05 16:10
- Flashback jag009 2012-04-05 17:51
- No correction if ≤5% Cmax Helmut 2012-04-05 18:08
- No correction if ≤5% Cmax navoday 2012-08-15 20:37
- excluded period(s) Helmut 2012-08-16 16:36
- excluded period(s) rajasekharkakarla 2019-09-20 07:57
- excluded period(s) Helmut 2012-08-16 16:36
- No correction if ≤5% Cmax navoday 2012-08-15 20:37
- No correction if ≤5% Cmax Helmut 2012-04-05 18:08
- Flashback jag009 2012-04-05 17:51
- Flashback Helmut 2012-04-05 16:10
- >6 sources of matrix jag009 2012-03-30 20:40
- >6 sources of matrix Helmut 2012-03-30 15:16
- Reanalysis if possible jag009 2012-03-30 15:06
- Reanalysis if possible Helmut 2012-03-29 23:17
- 0 hr Pre-dose concentration but less than 5% of Cmaxjag009 2012-03-29 20:10
- 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50
Ing. Helmut Schütz