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pash413 ★ India, 2015-12-07 14:22 (3849 d 20:29 ago) Posting: # 15702 Views: 6,832 |
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Dear all I need help to understand the dose to be administered for enzalutamide 40mg Capsule BE study. As per recently published OGD recommendation dose is "Strength: 40 mg at a dose of 160 mg (4x40mg", however reported Cmax for for 160 mg is 3.6 µg/mL. Can we perform study with single capsule administration for studies to be perform other than USFDA submission, because looking at the reported Cmax it will be possible to measure the concentrations with single capsule (40mg Dose). Note; As per product lable single daily dose is 160 mg (4x 40mg) Edit: Category changed and guidance linked. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2015-12-07 18:59 (3849 d 15:51 ago) @ pash413 Posting: # 15704 Views: 5,589 |
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Hi Pash, recommending for the highest dose is not uncommon for the FDA. ❝ Can we perform study with single capsule administration for studies to be perform other than USFDA submission… Which other agency do you have in mind? For the EMA it is the highest strength (not the dose). Last March at the ”Global Bioequivalence Harmonisation Initiative” this was exactly the issue where harmonisation seemed to lie in the far future. One presentation by Jack Cook (Pfizer US) was entitled “Differences in USA vs. EU approach: highest dose vs. highest dose strength”. Heated debates.  — 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