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Registerlinear PK! [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2014-04-18 14:16 (4456 d 21:53 ago) – Posting: # 12856
Views: 3,623
Hi Dan & wien-ui,
I agree with Dan – if linear PK is proven. We once had a case where – although linear PK was claimed for the reference – the German BfArM wanted an in vivo dose proportionality study of the different strengths of the test.
I agree with Dan – if linear PK is proven. We once had a case where – although linear PK was claimed for the reference – the German BfArM wanted an in vivo dose proportionality study of the different strengths of the test.
—
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. 🚮
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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:
- Reference for Biowaiver wien-ui 2014-04-17 14:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reference for Biowaiver Dr_Dan 2014-04-17 17:58
- Reference for Biowaiver wien-ui 2014-04-17 19:08
- Reference for Biowaiver Dr_Dan 2014-04-18 11:32
- linear PK!Helmut 2014-04-18 12:16
- Reference for Biowaiver wien-ui 2014-04-18 13:17
- Reference for Biowaiver Dr_Dan 2014-04-18 11:32
- Reference for Biowaiver wien-ui 2014-04-17 19:08
- Reference for Biowaiver Dr_Dan 2014-04-17 17:58
Ing. Helmut Schütz