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RegisterLinearity for Biowaiver (Literature) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2010-07-08 05:41 (5836 d 20:19 ago) – Posting: # 5600
Views: 4,899
Dear Stefano,
I think you mixed up the confirmatory assessment of dose proportionality (generally from a cross-over study of different strengths) and EMA's requirement to apply for a biowaiver. At the recent EGA Symposium on Bioequivalence Jan Welink (Dutch Medicines Agency, CBG|MEB) clarified this point:
I think you mixed up the confirmatory assessment of dose proportionality (generally from a cross-over study of different strengths) and EMA's requirement to apply for a biowaiver. At the recent EGA Symposium on Bioequivalence Jan Welink (Dutch Medicines Agency, CBG|MEB) clarified this point:
- linear PK of API = difference dose adjusted mean AUCs <25% between studied strength and to be waived strength(s)
- based upon all available data in the public domain
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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:
- Linearity in the new EMA guideline vezz 2010-07-07 09:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Linearity for Biowaiver (Literature)Helmut 2010-07-08 03:41
- Linearity for Biowaiver (Literature) vezz 2010-07-08 09:55
- Dose proportionality Helmut 2010-07-08 13:21
- Dose proportionality martin 2010-07-12 12:44
- Dose proportionality Helmut 2010-07-08 13:21
- Linearity for Biowaiver (Literature) vezz 2010-07-08 09:55
- Linearity for Biowaiver (Literature)Helmut 2010-07-08 03:41
Ing. Helmut Schütz