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RegisterCmax at tlast [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-12-07 16:29 (4945 d 02:05 ago) – Posting: # 9689
Views: 11,392
Dear Pash!
What was your sampling schedule? Did these subjects show low concentrations as well? Did you observe this effect both after test and reference or only after the reference? See this nasty example.
What do you mean by “shall we”? What does your protocol state? To which regulatory agency will you submit the study?
❝ One small confusion how to control last point Cmax in Fed BE study of prazole DR tablets. In some subjects Cmax is observed in last time points.
What was your sampling schedule? Did these subjects show low concentrations as well? Did you observe this effect both after test and reference or only after the reference? See this nasty example.
❝ Shall we exclude data of such subjects from final BE calculation?
What do you mean by “shall we”? What does your protocol state? To which regulatory agency will you submit the study?
—
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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:
- Omeprazole joyjac 2012-05-15 09:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Omeprazole drgunasakaran1 2012-05-15 09:50
- Omeprazole Helmut 2012-05-15 19:00
- Omeprazole pash413 2012-12-06 18:09
- Cmax at tlastHelmut 2012-12-07 15:29
- Omeprazole, widen of Cmax in a normal crossover design? wienui 2016-04-07 11:00
- Omeprazole reference = HVDP Helmut 2016-04-07 12:57
- Omeprazole pash413 2012-12-06 18:09
- Omeprazole Helmut 2012-05-15 19:00
- Omeprazole drgunasakaran1 2012-05-15 09:50
Ing. Helmut Schütz