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.
Simulations Plus to Present at Baird 2022 Global Healthcare Conference
Management will be presenting at Baird’s 2022 Global Healthcare Conference
Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment
With an increasing need to incorporate new approach methodologies (NAMs) in chemical risk assessment and the concomitant need to phase out animal testing, the interpretation of...
A novel transdermal ketoprofen formulation for analgesia in cattle
Ketoprofen is registered in many countries for injectable administration in cattle.
Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept
To date, mechanistic modeling of oral drug absorption has been achieved via the use of physiologically based pharmacokinetic (PBPK) modeling, and more specifically, physiologically...
Simulations Plus Releases State-of-the-Art QSP Software for Interstitial Lung Disease
ILDsym will enable new software and services revenue by aiding development of therapies for the treatment of patients with ILD as a complication of systemic sclerosis
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.
Metabolism of 3-Chlorobiphenyl (PCB 2) in a Human-Relevant Cell Line: Evidence of Dechlorinated Metabolites
Lower chlorinated polychlorinated biphenyls (LC-PCBs) and their metabolites make up a class of environmental pollutants implicated in a range of adverse outcomes in...
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.
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. The risk of intraluminal compound precipitation has been studied in vivo...
Physiologically based pharmacokinetic modeling of daptomycin dose optimization in pediatric patients with renal impairment
Daptomycin is used to treat Gram-positive infections in adults and children and its dosing varies among different age groups.
August 2022 GastroPlus Newsletter
As the summer season heats up here in New England, we invite you all to join us in honoring 2022 World Lung Cancer Day.
In Vitro–In Vivo Relationship in Mini-Scale—Enabling Formulations of Corallopyronin A
In vivo studies in mice provide a valuable model to test novel active pharmaceutical ingredients due to their low material need and the fact that mice are frequently used as a species...
Reliance is key to effective access and oversight of medical products in case of public health emergencies
Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators.