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RegisterWhich regulatory agency? [Design Issues]
posted by Helmut 
– Vienna, Austria, 2015-12-07 18:59 (3855 d 13:09 ago) – Posting: # 15704
Views: 5,616
Hi Pash,
recommending for the highest dose is not uncommon for the FDA.
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.
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.
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Helmut Schütz
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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
Complete thread:
- Enzalutamide pash413 2015-12-07 13:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Which regulatory agency?Helmut 2015-12-07 17:59
Ing. Helmut Schütz