Log in
RegisterRecommendations to Brinzolamide and Nepafenac from FDA [Design Issues]
Thank you ElMaestro. I share of your position.
There is a same situation to Nepafenac 0,1% and 0,3%. The FDA suggest bioequivalence studies with clinical endpoints, however there are data that indicating low plasma concentrations, but quantifiable, of nepafenac and amfenac observed in most individuals 2 and 3 hours post dose, respectively, after bilateral ocular topical dose 3 times per day nepafenac ophthalmic suspension 0.1%. Therefore, if there are levels measurable in human plasm a pharmacokinetic approach could be applied. I could be wrong, but I do not understand the reason for option clinical. If you or anybody else can explain, I really appreciate!
Regards!
There is a same situation to Nepafenac 0,1% and 0,3%. The FDA suggest bioequivalence studies with clinical endpoints, however there are data that indicating low plasma concentrations, but quantifiable, of nepafenac and amfenac observed in most individuals 2 and 3 hours post dose, respectively, after bilateral ocular topical dose 3 times per day nepafenac ophthalmic suspension 0.1%. Therefore, if there are levels measurable in human plasm a pharmacokinetic approach could be applied. I could be wrong, but I do not understand the reason for option clinical. If you or anybody else can explain, I really appreciate!
Regards!
Complete thread:
- Recommendations to Brinzolamide from FDA Mauricio Sampaio 2015-01-04 18:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Recommendations to Brinzolamide from FDA ElMaestro 2015-01-04 22:51
- Recommendations to Brinzolamide and Nepafenac from FDAMauricio Sampaio 2015-01-06 20:34
- Recommendations to Brinzolamide and Nepafenac from FDA ElMaestro 2015-01-06 22:00
- Recommendations to Brinzolamide and Nepafenac from FDAMauricio Sampaio 2015-01-06 20:34
- Recommendations to Brinzolamide from FDA ElMaestro 2015-01-04 22:51
Ing. Helmut Schütz