Topical pharmacokinetics of brinzolamide suspensions in rabbits and variability analysis for sample size and design considerations

Author:

Naageshwaran Vatsala,Bigonne HélèneORCID,Gum Glenwood,Malla Spundana,del Sol Charity,Bon Charles,Xu XiaomingORCID,Vo Anh,Smith William,O'Reilly Beringhs Andre,Kozak Darby,Tan Ming-LiangORCID,Babiskin Andrew,Urtti Arto,del Amo Eva M.,Ranta Veli-Pekka

Funder

U.S. Food and Drug Administration

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference14 articles.

1. Approval of Topical Ophthalmic Generic Products in the USA: Simple to Complex Dosage Forms and Establishing Equivalency;Choi,2021

2. Ocular intracameral pharmacokinetics for a cocktail of timolol, betaxolol, and atenolol in rabbits;Fayyaz;Mol. Pharm.,2020

3. In vitro physicochemical characterization and dissolution of brinzolamide ophthalmic suspensions with similar composition;Vo;Int. J. Pharm.,2020

4. Analyzing ophthalmic suspension particle size distributions using laser diffraction: Placebo background subtraction method;Vo;Int. J. Pharm.,2021

5. FDA, 2021. Product-Specific Guidances for Generic Drug Development.

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