Log in
RegisterDo your homework first [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2022-09-01 18:40 (988 d 10:59 ago) – Posting: # 23257
Views: 2,473
Hi Mithu,
Do you see the tab on top of the page?
For the EMA see the current guideline Section 6.8.2. AFAIK, not required for the FDA.
❝ My question is, in steady state studies, does 90% CI is mandatory to apply for Ctau? I believe it is secondary parameter and requires to submit as supportive Pharmacokinetic.
Do you see the tab on top of the page?
For the EMA see the current guideline Section 6.8.2. AFAIK, not required for the FDA.
—
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:
- Application of 90% CI for Ctau Mithu 2022-09-01 06:55 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Do your homework firstHelmut 2022-09-01 16:40
Ing. Helmut Schütz