Log in
RegisterEnantiomer measurement for metabolite [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-12-24 15:29 (4926 d 03:13 ago) – Posting: # 9754
Views: 3,004
Dear MSMN!
The GL continues with:
The GL continues with:
The individual enantiomers should also be measured if the above conditions are fulfilled or are unknown. If one enantiomer is pharmacologically active and the other is inactive or has a low contribution to activity, it is sufficient to demonstrate bioequivalence for the active enantiomer.
No idea how strict TGA enforces the “unknown” part. I changed to chiral methods almost all the time for the same reason just to learn from European regulators that most sponsors simply ignore this issue.—
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:
- Enantiomer measurement for metabolite msmnainar 2012-12-20 08:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Enantiomer measurement for metabolite drgunasakaran1 2012-12-22 12:28
- Enantiomer measurement for metabolite msmnainar 2012-12-24 06:40
- Enantiomer measurement for metaboliteHelmut 2012-12-24 14:29
- Enantiomer measurement for metabolite msmnainar 2012-12-24 06:40
- Enantiomer measurement for metabolite drgunasakaran1 2012-12-22 12:28
Ing. Helmut Schütz