Log in
RegisterConceptual flaw? [Design Issues]
posted by Helmut 
– Vienna, Austria, 2008-12-24 14:05 (6392 d 22:12 ago) – Posting: # 2976
Views: 3,209
Dear Santosh!
You mixed something up. If bioequivalence (extent and rate of bioavailability - or in FDA-speak total and peak exposure) of MR 18 mg is demonstrated vs. IR 3 x 6 mg (administered as a single dose), then it's also demonstrated that the product is not an MR formulation (which is not the intention)!
❝ if you administered reference product Thrice In a Day then each of Cmax will be at different time then how will you show the equivalence with test Cmax.
You mixed something up. If bioequivalence (extent and rate of bioavailability - or in FDA-speak total and peak exposure) of MR 18 mg is demonstrated vs. IR 3 x 6 mg (administered as a single dose), then it's also demonstrated that the product is not an MR formulation (which is not the intention)!
—
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:
- BE study of Single Vs Multiple raghu 2008-12-24 10:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study of Single Vs Multiple santosh.awale 2008-12-24 12:55
- Conceptual flaw?Helmut 2008-12-24 13:05
- Comparative BA (MR vs. IR) Helmut 2008-12-24 13:00
- BE study of Single Vs Multiple santosh.awale 2008-12-24 12:55
Ing. Helmut Schütz