Flashback [Regulatives / Guidelines]
Hi Helmut,
Question, can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...
Thanks
John
❝ ❝ Should the lab adjust the concentration profile to remove the residual levels caused by the pre-dose concentration???? ie. using the t1/2 and determine the amount of pre-dose concentration remaining throughout the timepoints and subtract it from the respective concentrations.
❝
❝ See above. I cannot imaging that any regulatory agency would accept this (any more).
Question, can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...
Thanks
John
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
- Flashbackjag009 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
- Flashbackjag009 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