estimated AUC72 [NCA / SHAM]
❝ In fact I would like to add a situation I have faced in couple of studies for pMDI formulation (with and without charcoal treatment), for Salmeterol I got AUC% extrapolation more than 20 % in about 35 % of the population and most of the subjects achieved either zero concentration much before the last concentration or had very slight concentration at last time point, actually a straight line was seen in the elimination phase because of which although samples were collected sufficient time period (up to 18 hrs post dose), AUC% extrapolation was greater than 20%. Following is a profile typically seen in most of the subjects but we got a query from regulator over it for validity of the as per guideline?
Let me make sure I deciphered your question correctly. 1) Are you talking about BE studies (T vs R)? 2) You said some subjects showed AUClast up to 8 hrs only for both T and R, while some showed AUClast up to a longer collection time? If so, I don't understand your concern. What query would the agency have? I can see the issue if the same subject shows AUC only up to 8 hrs for Test but AUC up to a longer collection time for Reference.
I recently ran a highly variable drug BE study. AUCs were a mess with subjects having
- undetectable concentration after 4 hr sampling
- undetectable concentrations after 12 hr sampling
- all concentrations above LLQ at end of collection time of 48 hrs.
Complete thread:
- Actual time for PK analysis ratnakar1811 2013-10-07 08:07
- estimated AUC72 Helmut 2013-10-07 13:36
- estimated AUC72 ratnakar1811 2013-10-08 08:20
- estimated AUC72 sam 2013-10-08 13:15
- estimated AUC72 Helmut 2013-10-08 13:51
- estimated AUC72 ratnakar1811 2013-10-10 11:30
- estimated AUC72jag009 2013-10-13 21:17
- estimated AUC72 ratnakar1811 2013-10-15 06:23
- estimated AUC72 Dr_Dan 2013-10-15 12:24
- estimated AUC72 jag009 2013-10-15 21:53
- estimated AUC72 ratnakar1811 2013-10-17 09:34
- estimated AUC72 ratnakar1811 2013-10-15 06:23
- estimated AUC72jag009 2013-10-13 21:17
- estimated AUC72 ratnakar1811 2013-10-10 11:30
- estimated AUC72 ratnakar1811 2013-10-08 08:20
- estimated AUC72 Helmut 2013-10-07 13:36