This report summarizes the proceedings of Session 1 of the one-day public workshop titled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023.
High vs. Low Vancomycin Therapeutic Concentrations in Periprosthetic Joint Infection: A Retrospective Cohort Analysis
Current guidelines recommend vancomycin concentrations of 10–20 μg/mL for most infections, with higher levels (15–20 μg/mL) suggested for severe cases.
Accelerating Small Molecule GLP-1 Agonist Optimization: AI-Driven Design Meets Mechanistic Modeling for a First-to-Invent Advantage
In a fast-paced industry with big budget competition, you need every tool and approach to succeed.
PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations
This report summarizes the proceedings for Session 3 of the one-day public workshop entitled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” a jointly sponsored workshop by U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023.
In Vitro and In Vivo Pharmacokinetic Characterization of 7-Hydroxymitragynine, an Active Metabolite of Mitragynine, in Sprague-Dawley Rats
Kratom, a Southeast Asian tree, has been researched for its potential as a therapeutic for substance use disorders.
Antiviral Activity of Halogenated Compounds Derived from L-Tyrosine Against SARS-CoV-2
Currently, there are no effective medications for treating all the clinical conditions of patients with COVID-19.
Trends in Drug-Drug Interactions for New Drug Clinical Trials in China Over the Past 10 Years (2013–2022)
The number of drug-drug interaction (DDI) clinical trials in China has increased rapidly in recent years.
Unveiling the Phenolic Profiling of Moroccan Ferula communis L. Fruits: A Combination of In Silico and In Vivo Protective Effect Against Methotrexate-Induced Hepato-Renal Dysfunction
Methotrexate (MTX) is associated with several side effects, including hepatic and renal toxicities, which limit its effectiveness as an anticancer medication.
Molluscicidal and Schistosomicidal Activities of 2-(1H-Pyrazol-1-yl)-1,3,4-thiadiazole Derivatives
Schistosomiasis is caused by flatworms of the genus Schistosoma, for which mollusks of the genus Biomphalaria are intermediate hosts.
Longitudinal Model-Based Meta-Analysis (MBMA) Comprehensive MonolixSuite Tutorial with Case Studies
Model-based meta analysis (MBMA) informs key drug development decisions by integrating data, published or unpublished, from multiple studies.
Clustering of Environmental Compounds Based on Structure and Toxicokinetic Properties
Traditional toxicokinetic (TK) models rely heavily on in vivo data, necessitating animal testing. At the same time, the scientific toolbox is expanding with new approach methodologies (NAMs) that do not rely on TK studies.
Leveraging Omeprazole PBPK/PD Modeling to Inform Drug–Drug Interactions and Specific Recommendations for Pediatric Labeling
Omeprazole is widely used for managing gastrointestinal disorders like GERD, ulcers, and H. pylori infections.
Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus to Predict Hepatic Concentrations
Infliximab, ipilimumab, and nivolumab are three monoclonal antibodies that have been associated with hepatotoxicity.
Mastering DDI Risk Assessment: Predict CYP enzyme-mediated DDIs with confidence
Understanding and predicting drug-drug interactions (DDIs) is crucial for ensuring patient safety and improving drug product development strategies.
Simulations Plus to Present at the KeyBanc Capital Markets Virtual Healthcare Investor Forum
Simulations Plus will be participating in a fireside chat at the KeyBanc Capital Markets Virtual Healthcare Investor.
RSM and AI Based Machine Learning for Quality by Design Development of Rivaroxaban Push-Pull Osmotic Tablets and its PBPK Modeling
The study is based on applying Artificial Neural Network (ANN) based machine learning and Response Surface Methodology (RSM) as simultaneous bivariate approaches in developing controlled-release rivaroxaban (RVX) osmotic tablets.
A Physiologically Based Pharmacokinetic Model of an Oral Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Adults
This study presents the first physiologically based pharmacokinetic (PBPK) model for deucravacitinib, a novel oral selective tyrosine kinase 2 (TYK2) inhibitor approved for treating moderate-to-severe plaque psoriasis.
Breaking Barriers in PROTAC Design: Improving Solubility of USP7-Targeting Degraders
The development of von Hippel–Lindau (VHL) hijacking proteolysis-targeting chimeras (PROTACs) has been hindered by suboptimal physicochemical properties, including high total polar surface area (TPSA), high hydrogen bond donor (HBD) counts, and poor solubility.
The Sooner, the Better: Early Drug Development Predictions to Assist in Prioritization of Drug Candidates and Resources
As the adage goes, “time is money,” and the drug development pipeline is no exception. Separately, both “time” and “money” are crucial considerations at every stage of drug development