Log in
RegisterNo stats [General Statistics]
posted by Helmut 
– Vienna, Austria, 2013-05-23 14:03 (4764 d 19:04 ago) – Posting: # 10628
Views: 4,565
Hi Ken!
The ASEAN draft GL Section 3.1.8 states “A statistical evaluation of tmax is not required.”
tmax is not required for ages. FDA wants partial AUC truncated at the median tmax of the reference as metric of early exposure.
❝ ❝ Wait until the draft will be finalized: No statistical comparison any more.
❝ May I know which guideline ?
The ASEAN draft GL Section 3.1.8 states “A statistical evaluation of tmax is not required.”
❝ FDA ?
tmax is not required for ages. FDA wants partial AUC truncated at the median tmax of the reference as metric of early exposure.
—
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:
- Tmax, ke and t1/2 in fully replicate design of HVD Ken Peh 2013-05-21 19:24 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz