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RegisterAUC truncated at 72 hours [Design Issues]
posted by Helmut 
– Vienna, Austria, 2008-05-23 16:09 (6608 d 22:32 ago) – Posting: # 1868
Views: 5,026
Dear DLabes!
Oh, this is very bad news!
Obviously at my BE workshop in Istanbul I failed in persuading MoH regulators that truncated AUC is a reasonable approach...
The ominous ‘MoH Circular’ from Jan 2006 states:
❝ But if you go not to Turkey.
❝ There we have experienced repeatedly requests from the authority or their assessors to sample up to 216 h for long half-life drugs.
Oh, this is very bad news!
Obviously at my BE workshop in Istanbul I failed in persuading MoH regulators that truncated AUC is a reasonable approach...
The ominous ‘MoH Circular’ from Jan 2006 states:
- Sampling
○ The sampling time should cover at least three or more times the terminal half-life of the
active substance.
○ Sampling should be done frequently enough to express Cmax and the terminal elimination
phase.
—
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:
- AUC truncated drcampos 2008-05-09 05:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC truncated at 72 hours Helmut 2008-05-17 16:34
- AUC truncated at 72 hours d_labes 2008-05-23 08:52
- AUC truncated at 72 hoursHelmut 2008-05-23 14:09
- AUC truncated at 72 hours d_labes 2008-05-23 08:52
- AUC truncated at 72 hours Helmut 2008-05-17 16:34
Ing. Helmut Schütz