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PBPK Modeling for Identifying and Mitigating Absorption Risks in Early Drug Development
Physiologically based pharmacokinetic (PBPK) models represent animals and humans virtually as a collection of organs and tissues, each defined by a system of mathematical equations
Investigating the influence of the type of polymer on sustaining the supersaturation from amorphous solid dispersions of Apremilast and its pharmacokinetics
Apremilast, a BCS class IV drug, has minimal solubility in aqueous medium which results in poor bioavailability.
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Besifloxacin Suspension Case Study
The purpose of this research is to demonstrate the ability of O-PBPK models, validated against rabbit PK data, to predict clinical ocular exposure, following topical administration of ophthalmic suspensions
Validation of PBPK-Based Translation to Predict Monoclonal Antibody Pharmacokinetics in Pediatric Populations
Accurate prediction of the pediatric dose is a necessity before conducting a clinical trial or using a drug product in standard clinical practices.
Next generation risk assessment of human exposure to estrogens using safe comparator compound values based on in vitro bioactivity assays
In next generation risk assessment (NGRA), the Dietary Comparator Ratio (DCR) can be used to assess the safety of chemical exposures to humans in a 3R compliant approach.
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets
Assessing in vivo performance to inform formulation selection and development decisions is an important aspect of drug development.
Simulations Plus Receives U.S. FDA Renewal for DILIsym Software Licenses
Provides FDA with software tools to investigate drug-induced liver injury in clinical trials
Pulmonary Package
Breathe Easy with our Pulmonary Package
Artificial Intelligence in Drug Metabolism and Excretion Prediction: Recent Advances, Challenges, and Future Perspectives
Drug metabolism and excretion play crucial roles in determining the efficacy and safety of drug candidates, and predicting these processes is an essential part of drug discovery and development.
Enhancing Drug-Drug Interaction Prediction by Integrating Physiologically-Based Pharmacokinetic Model with Fraction Metabolized by CYP3A4
Enhancing the precision of drug-drug interaction (DDI) prediction is essential for mitigating potential drug interactions and enhancing drug safety and efficacy.
Model conception, parameterization using in silicomethods, and computational implementation
The PKB model structure depends on the problem, knowledge of the biokinetic mechanism, and availability of suitable data
The Involvement of Hypoxia in the Response of Neuroblastoma Cells to the Exposure of Atorvastatin
Cancer is a set of complex diseases, being one of the leading causes of death worldwide.
April 2023 GastroPlus Newsletter
Happy Spring! (for those of us that are North of the Equator)
Effect of Food and a Proton-Pump Inhibitor on the Absorption of Encorafenib: An In Vivo–In Vitro–In Silico Approach
Encorafenib is a kinase inhibitor indicated for the treatment of patients with BRAF mutant melanoma and BRAF mutant metastatic colorectal cancer.
Quantitative Systems Toxicology (QST) Modeling Using DILIsym Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia (AML) Patients
Clinical investigation of emvododstat for the treatment of solid tumors was terminated after two patients who were heavily...
Development of a Quantitative Systems Toxicology Model of Multidrug Resistance Protein 3 (MDR3) Inhibition to Predict Bile Acid Mediated Cholestatic Drug Induced Liver Injury
Multidrug resistance protein 3 (MDR3) translocates phospholipids (PLs) from the inner to the outer leaflet of the canalicular...
Simulations Plus Reports Second Quarter Fiscal 2023 Financial Results
Total revenue of $15.8 million; Diluted Earnings Per Share (EPS) of $0.20;
Maintains full-year revenue guidance of $59.3 - $62.0 million (+10-15%) and EPS Guidance of $0.63 - $0.67
April 2023 News/ Events
PBPK Summer Camp, FIH Predictions Workshops, and in-person conferences