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NPavan ☆ India, 2009-06-04 14:29 (6224 d 08:01 ago) Posting: # 3819 Views: 5,108 |
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Dear all, We conducted a study with 23 sampling time points (upto 72 hrs). In that for reference product 23rd sampling time point, the concentration is showing missing. Now for comparing test and reference products, AUC for test product is AUC0_72 and reference product is AUC0_36. Now my question is, How to compare the test and reference products with respect to AUCt. Thanks in advance. — Regards, Pavan |
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Nirali ★ India, 2009-06-17 09:14 (6211 d 13:16 ago) @ NPavan Posting: # 3862 Views: 4,249 |
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Dear Npavan, pl. specify the regulatory of the study. As in my view, we shall follow below steps: 1) calculate AUC %extrapolation for the specific subject (who has missing sample at ambulatory time point) for reference product to check absorbtion process is complete or not. 2) if AUC %extrapolation is <20%, it assures that absorbtion process is complete. Thus, we can consider that subject for PK and statistical analysis and compare profile of test and referece product. 3) if AUC %extrapolation is >20%, it says absorbtion process is incomplete. Therefore, subject required to exclude from the PK and statistical analysis of the study since reference profile is not complete. Dear Friends, pls correct this if anything is lacking here. Thanks & Regards, NIRALI |
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Helmut ★★★   Vienna, Austria, 2009-06-17 13:56 (6211 d 08:34 ago) @ Nirali Posting: # 3865 Views: 4,130 |
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Dear Nirali! ❝ 2) if AUC %extrapolation is <20%, it assures that absorbtion process is ❝ complete. Thus, we can consider that subject for PK and statistical ❝ analysis and compare profile of test and referece product. See the first plot in this post. The absorption phase (red line) is almost complete after 2 hours. Imagine a situation where both formulations give identical profiles (FT=FR; blue line) and one sample of T is missing at 6 hours. Both AUCt will be >80% of AUCinf (T: AUC5 41.5, 83.1% of AUCinf; R: AUC6 44.3, 88.7%). Following your suggestion (absorption complete, comparing AUCt) would lead to a biased result of F=93.7% (see also this post).
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz