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RegisterAUC truncation for MR: depends… [NCA / SHAM]
posted by Helmut 
– Vienna, Austria, 2012-01-05 20:06 (4867 d 15:03 ago) – Posting: # 7868
Views: 4,062
Dear Rana!
Good point. Please give us more details – MR is a too general term.
Personal views: For delayed release and some kind of pulsatile formulations it should not be a problem (latest phase of the profile = elimination). For controlled release going beyond flip flop PK (latest phase = absorption!) I would be very wary. It seems that EMA in the new MR guideline will ask for AUC∞.
❝ Whether it is possible to Truncate AUC upto 72.0 hrs in modified release formulations???
Good point. Please give us more details – MR is a too general term.
Personal views: For delayed release and some kind of pulsatile formulations it should not be a problem (latest phase of the profile = elimination). For controlled release going beyond flip flop PK (latest phase = absorption!) I would be very wary. It seems that EMA in the new MR guideline will ask for AUC∞.
—
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 truncation in Modified release formulations rana 2012-01-05 14:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC truncation for MR: depends…Helmut 2012-01-05 19:06
- AUC truncation in Modified release formulations raoofkhan 2012-01-09 20:29
Ing. Helmut Schütz