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RegisterDelayed release? [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2012-10-15 18:41 (5006 d 03:21 ago) – Posting: # 9418
Views: 4,722
Good morning!
If both AUC and Cmax were equivalent, you are speaking of a DR formulation, right?
Personal experience only in the “etc.” category. See this goody (especially Case Study 2).
❝ […] studies whereby the test and reference products were bioequivalent but Tmax values were very different, i.e. T=6 hrs, R=12 hrs, p<0.05? Lets say both sample size (>24) and Sampling time (hourly) were sufficient.
If both AUC and Cmax were equivalent, you are speaking of a DR formulation, right?
❝ Any roadblocks from regulatory agency (US, Europe, etc.)
Personal experience only in the “etc.” category. See this goody (especially Case Study 2).
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 differences in BE studies jag009 2012-10-15 16:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Delayed release?Helmut 2012-10-15 16:41
- Delayed release? jag009 2012-10-15 19:38
- Delayed release?Helmut 2012-10-15 16:41
Ing. Helmut Schütz