As I think back on 20+ years of lecturing on the population modeling & simulation (M&S) approach, I am simultaneously struck by how much has changed and how much has remained the same.
Ensuring the Quality and Accuracy of Analysis-Ready Datasets
Our experience in data assembly is extensive: we’ve been building analysis-ready datasets for pharmacometric modeling and simulation for over 25 years.
June 2021 GastroPlus Newsletter
A long time ago, in a desert far, far away…
Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets
The generic drug product DRL ABC is an Extended Release (ER) Tablet manufactured by Dr. Reddy’s Laboratories Limited and have multi point dissolution as part of release specification.
Meta-Assessment of Metformin Absorption and Disposition Pharmacokinetics in Nine Species
The objective of this study was to systematically assess literature datasets and quantitatively analyze metformin PK in plasma and some tissues of nine species.
Simulation of Remdesivir Pharmacokinetics and Its Drug Interactions
Remdesivir, a drug originally developed against Ebola virus, is currently recommended for patients hospitalized with coronavirus disease of 2019 (COVID-19).
Relationship Between Pimavanserin Exposure and Negative Symptoms in Patients With Schizophrenia: Data Analysis From the Phase 2 ADVANCE Study
Negative symptoms in schizophrenia are associated with poor psychosocial function and long-term outcomes yet no pharmacological treatments are currently approved in the United States to treat...
Application of physiologically based biopharmaceutics modeling (PBBM) to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years.
Oral APX3330 treatment reduces L-CNV lesions in preclinical mouse model and confirms Phase 2 DR/DME clinical dose with sufficient distribution to human retina using PBPK modeling
APX3330 is a small molecule inhibitor of Ref-1, a target involved in key vascular and inflammatory ocular disease processes including diabetic retinopathy (DR), diabetic macular edema (DME) and wetAMD.
Particle Deposition in Respiratory Tract: Where are the Limits?
In last two decades in silico biopharmaceutics modelling has become increasingly important in all stages of drug development.
Simulations Plus to Participate in 18th Annual Craig-Hallum Institutional Investor Conference
Simulations Plus to Participate in 18th Annual Craig-Hallum Institutional Investor Conference
Installing ADMET Predictor on Linux OS
Installation instructions for ADMET Predictor® using Linux OS
COVID-19 vaccines and treatments: When speed is necessary and not enough
The infectivity and severity of the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic (coronavirus disease 2019 [COVID-19]) has fostered the need for speed in the work to make progress against the virus.
Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments
Sildenafil is the active substance in Viagra® tablets, which is approved by the FDA to treat sexual dysfunction in men. Poor solubility and short half-life, however, can limit the span of its effectiveness.
Simulx Webinar: Optimizing Sample Size of a Phase III trial
What if we could reduce the size of a phase III study from 400 to 80 subjects and make it twice as short? Thanks to model-informed clinical trial design, it's possible!
Scaling Approaches for Pediatric Dose Selection: the Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data From a Phase 1 Study. Pharmaceuticals
Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and
Pulmonary PBPK Modeling for Inhaled Products: Antibiotic Case Studies
What are we doing for inhaled products today?
NAFLDsym Application Showcase: Key Examples of NAFLDsym Use within Drug Development
NAFLDsym is a quantitative systems pharmacology (QSP) modeling software to support the development of treatments for non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).