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Mei San ☆ Malaysia, 2015-03-03 06:36 (3335 d 10:42 ago) Posting: # 14534 Views: 6,349 |
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Dear all, May I know if anyone has experience on orlistat 120mg BE study before? Many thanks. Regards, Mei San. |
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Dr_Dan ★★ Germany, 2015-03-04 10:50 (3334 d 06:28 ago) @ Mei San Posting: # 14548 Views: 5,396 |
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Dear Mei San The PD Endpoint is the percent of fecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat. Sounds awful...... Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2015-03-04 11:39 (3334 d 05:39 ago) @ Dr_Dan Posting: # 14549 Views: 5,385 |
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...but appears doable, as I found at least one EPAR on such a study. As usual in recent times, no sample size was stated, but as CVintras were provided, apparently between 40 and 50 volunteers were included... Most likely based on one of these infamous (dubious?) pilot studies  — Kindest regards, nobody |
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luvblooms ★★ India, 2015-03-09 07:44 (3329 d 09:34 ago) @ nobody Posting: # 14552 Views: 5,354 |
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Done one study on orlistat. And believe me, it is going to be a tough one!! (main problem was keeping volunteers in the facility for ~45-60 day apart from the faecal collection method). But we did that and failed  Do check this one too Pharmacodynamic equivalence of two orlistat capsule formulations in healthy volunteers under fed conditions. Hope this will help — ~A happy Soul~ |
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patilatu ☆ 2015-03-09 08:36 (3329 d 08:42 ago) @ luvblooms Posting: # 14553 Views: 5,220 |
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Dear All, ❝ Done one study on orlistat. ❝ ❝ And believe me, it is going to be a tough one!! (main problem was keeping volunteers in the facility for ~45-60 day apart from the fecal collection method). Yes, I agree. It is logistically very tough. The volunteer availability is a big issue for such a long period. regards Patilatu |
Ing. Helmut Schütz