Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

Publication: Pharmaceutical Research
Software: GastroPlus®
Division: Simulations Plus

The development of generic ophthalmic drug products is challenging due to the complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of physiology with ophthalmic formulations.

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

Software: GastroPlus®
Division: Simulations Plus

Students have an increased interest in learning physiologically based pharmacokinetic (PBPK) modeling, but this requires an in-depth understanding of biopharmaceutics and pharmacokinetics.

Project Optimus –FDA’s “New” Dose Optimization & Selection Paradigm in Oncology Drug Development

Project Optimus –FDA’s “New” Dose Optimization & Selection Paradigm in Oncology Drug Development

Dr. Brian P. Booth and Dr. Hao Zhu from the Office of Clinical Pharmacology (OCP) at the FDA will present and discuss Project Optimus, an initiative from the Oncology Center of Excellence (OCE) to reform the dose optimization and dose selection paradigm in oncology drug development.

Physiologically Based Biopharmaceutics Model for Selumetinib Food Effect Investigation and Capsule Dissolution Safe Space – Part I: Adults

Physiologically Based Biopharmaceutics Model for Selumetinib Food Effect Investigation and Capsule Dissolution Safe Space – Part I: Adults

Publication: Pharmaceutical Research
Division: Simulations Plus

A physiologically based biopharmaceutics model (PBBM) was developed to mechanistically investigate the effect of formulation and food on selumetinib pharmacokinetics.