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RegisterGCC: HV Cmax (fixed limits) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2020-11-19 12:05 (548 d 19:52 ago) – Posting: # 22068
Views: 1,309
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.
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Dif-tor heh smusma 🖖
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