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SaraCHenriques ☆ Portugal, 2020-06-01 22:24 (1026 d 07:35 ago) Posting: # 21496 Views: 3,662 |
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Hi everyone!  During a Phase I bioequivalence trial of a TDDS, we recorded the adhesion of the patches (T and R), at the end of dosing interval, as percentage of area that remains adhered, according to EMA's Guideline. I ask if anyone could advise me on how to perform a non-inferiority analysis for this data, on Phoenix WinNonlin. Many thanks in advance! Sara Edit: Category changed; see also this post #1. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2020-06-14 14:05 (1013 d 15:54 ago) @ SaraCHenriques Posting: # 21538 Views: 2,490 |
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Hi Sara, sorry for not replying earlier. ❝ […] how to perform a non-inferiority analysis for this data, on Phoenix WinNonlin. Not directly supported in Phoenix. However, there is a simple workaround. Non-inferiority tests (and non-superiority as well) are one-sided. Perform the BE-analysis as usual in Phoenix (i.e., two-sided for equivalence at α 0.05) and assess whether the lower confidence limit is ≥80.00% of the reference. Ignore the upper limit. — 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 |
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SaraCHenriques ☆ Portugal, 2020-06-27 01:10 (1001 d 04:49 ago) @ Helmut Posting: # 21581 Views: 2,365 |
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Hi Helmut, Thank you so much for your answer! Regarding the fixed and random effects, do you have any recommendation? Should we use all effects fixed as for PK BE analysis; or only Subject and Treatment fixed as when comparing irritation scores? Thank you once again! Sara — Sara |
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Helmut ★★★ Vienna, Austria, 2020-06-29 16:54 (998 d 13:04 ago) @ SaraCHenriques Posting: # 21601 Views: 2,358 |
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Hi Sara, ❝ Regarding the fixed and random effects, do you have any recommendation? Should we use all effects fixed as for PK BE analysis; Since the PKWP seemingly is obsessed with “all effects fixed”, likely yes.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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SaraCHenriques ☆ Portugal, 2020-06-29 22:12 (998 d 07:47 ago) @ Helmut Posting: # 21606 Views: 2,334 |
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Hi Helmut Thank you very much! — Sara |
Ing. Helmut Schütz