Pimavanserin is a selective serotonin 5-HT2A receptor inverse agonist/antagonist being investigated in patients with negative symptoms of schizophrenia. This analysis aimed to characterize exposure-response relationships of...
Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study
In vitro-in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles...
Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation – Workshop Summary Report
To date, few examples of dissolution models for real-time release testing (RTRT) have been approved for commercial drug products or published in literature.
Can We Predict Clinical Pharmacokinetics of Highly Lipophilic Compounds by Integration of Machine Learning or In Vitro Data into Physiologically Based Models? A Feasibility Study Based on 12 Development Compounds
While high lipophilicity tends to improve potency, its effects on pharmacokinetics (PK) are complex and often unfavorable.
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.
Results from a Validated in vitro Gastrointestinal Model (TIM) used as input Data for in silico Modeling Give Highly Predictive Information for the Human Situation
The aim of this review paper is to evaluate the predictive quality of a combination of in vitro dynamic gastrointestinal models, mucosal transit models and in silico kinetic...
Translational Pharmacokinetics of a Novel Bispecific Antibody Against Ebola Virus (MBS77E) from Animal to Human by PBPK Modeling & Simulation
The goal of this study was to construct a PBPK model to accelerate the translation of MBS77E, a humanized bispecific antibody against the Ebola virus.
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients
Physiologically based pharmacokinetic (PBPK) models are considered useful tools in animal-free risk assessment.
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.
Gastrointestinal Fluid Volumes in Pediatrics: A Retrospective MRI Study
The volume and distribution of fluids available in the gastrointestinal (GI) tract may substantially affect oral drug absorption.
A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer
OC-001 is a CD137 mAb agonist designed to show differential agonistic activity from that of competitor
antibodies. OC-001 provided T cell activation that
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.
Implementation of a Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease-Related Changes in Drug Pharmacokinetics in Patients with Nonalcoholic Fatty Liver Disease Conference name: International Society for the Study of Xenobiotics (ISSX)-Microsomes and Drug Oxidations (MDO) Joint Meeting
Introduction: Understanding disease-related changes in the pharmacokinetics of drugs in patients with nonalcoholic fatty liver disease (NAFLD) is of clinical importance...
Absorption Predictions: Current Capabilities and Knowing the Gaps
Number of different processes contribute to net drug absorption
Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space
Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg.
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.