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RegisterStrength (EMA) vs. dose (FDA) [Design Issues]
posted by Helmut 
– Vienna, Austria, 2016-06-03 17:09 (3678 d 08:36 ago) – Posting: # 16391
Views: 5,789
Hi Deep,
please see this post #3. Contrary to the FDA (generally requiring the highest dose) the EMA requires the most sensitive strength (for the conditions see the BE-GL Section 4.1.6). Since you want to apply only for one strength, a single dose study in fasting state (1 × 3 mg) is sufficient.
please see this post #3. Contrary to the FDA (generally requiring the highest dose) the EMA requires the most sensitive strength (for the conditions see the BE-GL Section 4.1.6). Since you want to apply only for one strength, a single dose study in fasting state (1 × 3 mg) is sufficient.
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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:
- Selection of dose in BE study of Ivermectin 3 mg tabs for EU Deep patel 2016-06-03 13:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strength (EMA) vs. dose (FDA)Helmut 2016-06-03 15:09
- Strength (EMA) vs. dose (FDA) Deep patel 2016-06-04 13:18
- Strength (EMA) vs. dose (FDA)Helmut 2016-06-03 15:09
Ing. Helmut Schütz