Predicting Brinzolamide Ocular Response in Humans Using an Ocular PBPK-PD Modeling and Simulation

Authors: Le Merdy M, Mullin JM, Tan ML, Lukacova V
Conference: ASCPT
Keywords: clinical pharmacokinetics (PK), gastroplus, Ocular Compartmental Absorption and Transit (OCAT™), ocular PBPK-PD modeling, ophthalmic drug products
Software: GastroPlus®
Division: PBPK
Therapeutic Areas: Ophthalmology

Purpose

  • The development of generic ophthalmic drug products indicated for intraocular pressure (IOP) reduction typically relies on comparative pharmacodynamic (PD) endpoint bioequivalence (BE) studies.
  • These studies present challenges for the pharmaceutical industry due to their high costs and limited sensitivity to formulation differences.
  • More efficient BE methods are needed to support the development of generic IOP-reducing drug products.
  • Ocular physiologically based pharmacokinetic (O-PBPK) modeling is an alternative to support BE assessment of generic ophthalmic drug products.
  • There is an increasing number of case studies of O-PBPK models predicting clinical pharmacokinetics (PK) for ophthalmic drug products.
  • Brinzolamide (BRI) is a first-line medication for IOP diseases.

By Maxime Le Merdy, Jim Mullin, Ming-Liang Tan, Viera Lukacova