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RegisterRecommendations to Brinzolamide from FDA [Design Issues]
Recently the FDA published nonbinding recommendations to ophthalmic products like Brinzolamide (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384099.pdf) and suggest bioequivalence study with Clinical Endpoint. On the other hand to Prednisolone acetate suspension drops the recommendations are bioequivalence study with pharmacokinetic endpoints in appropriate biological fluid like aqueous humor (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384160.pdf).
Is possible a study to Brinzolamide with pharmacokinetic endpoint or the fact that Brinzolamide is a carbonic anhydrase inhibitor decreases aqueous humor secretion is the reason to this impossibility ?
Is possible a study to Brinzolamide with pharmacokinetic endpoint or the fact that Brinzolamide is a carbonic anhydrase inhibitor decreases aqueous humor secretion is the reason to this impossibility ?
Complete thread:
- Recommendations to Brinzolamide from FDAMauricio 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 FDA Mauricio 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 FDA Mauricio Sampaio 2015-01-06 20:34
- Recommendations to Brinzolamide from FDA ElMaestro 2015-01-04 22:51
Ing. Helmut Schütz