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Hitesh Chauhan ☆ India, 2015-08-19 09:47 (3496 d 02:40 ago) Posting: # 15298 Views: 4,744 |
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Hello, As per the regulatory criteria for partial AUC, the definition is AUC0-1.5 is the area under the plasma-concentration vs. time curve from 0 to 1.5 hours. For AUC0-1.5, if the 1.5hour concentration is missing due to any reason for one product, then do we have to exclude that subject from that product? Thanks Hitesh Edit: Category and subject line changed. Why did you shout? [Helmut] |
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d_labes ★★★ Berlin, Germany, 2015-08-19 12:20 (3496 d 00:07 ago) @ Hitesh Chauhan Posting: # 15301 Views: 3,712 |
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Dear Hitesh! ❝ For AUC0-1.5, if the 1.5hour concentration is missing due to any reason for one product, then do we have to exclude that subject from that product? That may be an option. But IMHO not the best. I usually do interpolation in such cases. The same is applied in case of time deviations at 1.5h or at whatever timepoint the partial AUC is needed. Don't forget the description of your choice how to deal with such cases in your Study protocol! — Regards, Detlew |
Ing. Helmut Schütz