Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Besifloxacin Suspension Case Study

Conference: ARVO
Software: GastroPlus®
Division: Simulations Plus


  • Development of generic ophthalmic drug products is challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations
  • Due to their poor sensitivity, and associated costs, comparative clinical endpoint bioequivalence (BE) studies for a generic ocular drug product are a significant challenge to the pharmaceutical industry
  • Ocular physiologically based pharmacokinetic (O-PBPK) modeling is an alternative to support regulatory assessment of ophthalmic drug products
  • O-PBPK models have already demonstrated their value to predict clinical pharmacokinetics (PK) for ophthalmic solutions1
  • The purpose of this research is to demonstrate the ability of O-PBPK models, validated against rabbit PK data, to predict clinical ocular exposure, following topical administration of ophthalmic suspensions

By Maxime Le Merdy, Farah AlQaraghuli, Viera Lukacova

Presented April 25th, 2023, Association for Research in Vision and Ophthalmology (ARVO) conference New Orleans, LA