Log in
RegisterGCC: HV Cmax (fixed limits) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2020-11-19 12:05 (676 d 10:22 ago) – Posting: # 22068
Views: 1,408
Hi nuka2020,
» According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%.
» … the results of Cmax is: 70.46%-141.90%
» Need suggestion whether this studies can be acceptable as per GCC guidelines??
What do you think?
Though you have practically a perfect PE (99.99%) you failed to show BE by far. For the GCC your study was just underpowered.
» According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%.
» … the results of Cmax is: 70.46%-141.90%
» Need suggestion whether this studies can be acceptable as per GCC guidelines??
What do you think?
Though you have practically a perfect PE (99.99%) you failed to show BE by far. For the GCC your study was just underpowered.
—
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. 🚮
Science Quotes
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:
- highly variable drugs-Cmax nuka2020 2020-11-19 11:09 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- GCC: HV Cmax (fixed limits)Helmut 2020-11-19 12:05
- highly variable drugs-Cmax wienui 2020-11-19 18:04
- highly variable drugs-Cmax Helmut 2020-11-19 20:58
Ing. Helmut Schütz