To date, few examples of dissolution models for real-time release testing (RTRT) have been approved for commercial drug products or published in literature.
Delineating the Complex Interplay of Enzymes and Transporters Governing the Absorption and Disposition of Atorvastatin and the Metabolites Using Physiologically Based Pharmacokinetic (PBPK) Modeling
Atorvastatin (ATS) is widely used to treat high cholesterol and potentially lower the risk of cardiac complications.
Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation
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
Students have an increased interest in learning physiologically based pharmacokinetic (PBPK) modeling, but this requires an in-depth understanding of biopharmaceutics and pharmacokinetics.
Simulations Plus to Present at Sidoti Fall Small Cap Investor Conference
Chief executive officer Shawn O’Connor will be presenting at the Sidoti Fall Small Cap Investor Conference taking place virtually on September 21-22, 2022.
Physiologically Based Pharmacokinetic (PBPK) Modeling of Pyrotinib to Understand the Impact of Interplay Between CYP3A4 and P-GP on its DDIs with CYP3A4 Inhibitors/Inducers
To develop a PBPK model for pyrotinib and qualify it with the in vivo data obtained after oral administrations.
Absorption Predictions: Current Capabilities and Knowing the Gaps
Number of different processes contribute to net drug absorption
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.
Simulations Plus to Present at Baird 2022 Global Healthcare Conference
Management will be presenting at Baird’s 2022 Global Healthcare Conference
A novel transdermal ketoprofen formulation for analgesia in cattle
Ketoprofen is registered in many countries for injectable administration in cattle.
Application of PBPK Modeling in Pediatric Drug Development (GastroPlus®)
Role of PBPK in Pediatric Drug Development
Physiologically Based Biopharmaceutics Model for Selumetinib Food Effect Investigation and Capsule Dissolution Safe Space – Part I: Adults
A physiologically based biopharmaceutics model (PBBM) was developed to mechanistically investigate the effect of formulation and food on selumetinib pharmacokinetics.
Simulation of Intraluminal Performance of Lipophilic Weak Bases in Fasted Healthy Adults Using DDDPlusTM
The majority of drug candidates exhibit weakly basic characteristics with high lipophilicity.
Multi-method global sensitivity analysis of mathematical models
Increasingly-sophisticated parameter-sensitivity analysis techniques continue to be developed, and each technique...
Simulations Plus Enters New Collaboration to Enhance Machine Learning Models for Ionization Constants (pKa)
Extensive data sharing with large pharmaceutical partner will expand property prediction space and improve model performance