No correction if ≤5% Cmax [Regulatives / Guidelines]
❝ ❝ […] can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...
Dear Helmut...
wishing you and all members of forum a very happy independence day (india)
should we submit statistical data with inclusion and exclusion of that subject having predose concentration more than 5% of Cmax or simply delete that subject from all analysis? what if study is partial replicate (3WSABE)and that subject has completed TR sequence? as it may help for estimating t1/2 and tmax if average bioequivalence is there.
Complete thread:
- 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34 [Regulatives / Guidelines]
- 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 Cmax jag009 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% Cmaxnavoday 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% Cmaxnavoday 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 Cmax jag009 2012-03-29 20:10
- 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50