estimated AUC72 [NCA / SHAM]
Hi,
My opinions (based on what I could gather from your description and the 2nd graph you posted in pre. posting):
One question, how's the solubility and permeability of the drug molecule?
Like Dr_Dan said "How did you compute AUCinf?"? If I recall correctly it is possible to throw out/conclude AUCinf as "not defined" due to ridiculous half-life value. How different were the t1/2 values for this 20% extrapolation data?
Thanks
John
❝ Situation 1: Situation somewhat similar to yours, where samples were collected up to 36 hrs post dose, but for some of the subjects AUCt could be calculated only up to 8 hrs, for some of the subjects it was up to 16 hrs and for some of the subjects up to 36 hrs.
My opinions (based on what I could gather from your description and the 2nd graph you posted in pre. posting):
- You meant you had subjects with AUCt up to 36 hrs for treatment A and AUCt only up to 8 hrs for treatment B (And the AUCt values are very different?)? Differences in t1/2 values? What is the pharm/PK property of the molecule? My crystal ball says the molecule may have auto-induction property such that it "enhances" the metabolism enzyme -> If you do a crossover study then you are cooked because the first period treatment would influence the metabolism capability such that the bioavailability of the 2nd period treatment would get reduced. I faced this issue a while back.
- Or you meant some subjects had only AUCt upto 8 hrs for both T and R while some subjects had AUCt upto 36 hrs for both T and R? If so, it's just the variability of the drug. If it's a BE study then what's the issue since we are interested in intra-subject comparison.
One question, how's the solubility and permeability of the drug molecule?
❝ Query 2: Since extrapolation is more than 20% how do we justify such situation?
Like Dr_Dan said "How did you compute AUCinf?"? If I recall correctly it is possible to throw out/conclude AUCinf as "not defined" due to ridiculous half-life value. How different were the t1/2 values for this 20% extrapolation data?
Thanks
John
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 AUC72 jag009 2013-10-13 21:17
- estimated AUC72 ratnakar1811 2013-10-15 06:23
- estimated AUC72 Dr_Dan 2013-10-15 12:24
- estimated AUC72jag009 2013-10-15 21:53
- estimated AUC72 ratnakar1811 2013-10-17 09:34
- estimated AUC72 ratnakar1811 2013-10-15 06:23
- estimated AUC72 jag009 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