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RegisterStrength selection [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-01-27 17:07 (5249 d 08:35 ago) – Posting: # 8009
Views: 4,405
Dear Paresh!
Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information.
❝ If reference drug having list of strength 10mg, 20mg, 40mg, and 80mg.
❝ I have developed all strength and need to conduct BE study on highest strength 80mg. But for reference can i select dose as 2x40mg=80 for BE study.
❝ Due to un availability of reference drug as 80mg.
Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information.
—
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:
- Strength selection Paresh 2012-01-27 06:47 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strength selectionHelmut 2012-01-27 16:07
- Strength selection Paresh 2012-01-28 11:29
- Strength selection Helmut 2012-01-28 14:27
- Strength selection Ohlbe 2012-01-28 18:20
- Swiss reference? Helmut 2012-01-28 18:30
- Swiss reference? Ohlbe 2012-01-28 22:31
- EU reference! Helmut 2012-01-29 03:51
- Swiss reference? Ohlbe 2012-01-28 22:31
- Swiss reference? Helmut 2012-01-28 18:30
- Strength selection Ohlbe 2012-01-28 18:20
- Strength selection Helmut 2012-01-28 14:27
- Strength selection Paresh 2012-01-28 11:29
- Strength selectionHelmut 2012-01-27 16:07
Ing. Helmut Schütz