Trofinetide is the first drug to be approved for the treatment of Rett syndrome.
Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product.
Simulations Plus Reports Third Quarter Fiscal 2024 Financial Results
Total revenue of $18.5 million and diluted earnings per share (EPS) of $0.15
Maintains full-year revenue guidance of $69 to $72 million and updates EPS guidance
The Synthetic Cathinones MDPHP and MDPV: Comparison of the Acute Effects in Mice, in silico ADMET Profiles and Clinical Reports
The 3,4-methylenedioxy-alpha-pyrrolidinohexanophenone (MDPHP) is a synthetic cathinone closely related to 3,4-methylenedioxypyrovalerone (MDPV), one of the most common synthetic cathinones present in the "bath salts".
Toward Personalized Salbutamol Therapy: Validating Virtual Patient-Derived Population Pharmacokinetic Model with Real-World Data
Interindividual variability, influenced by patient-specific factors including age, weight, gender, race, and genetics, among others, contributes to variations in therapeutic response.
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.
DILIsym® X Product Brochure
DILIsym is Quantitative Systems Toxicology (QST) software capable of predicting and explaining Drug-Induced Liver Injury (DILI).
Treating Systemic Lupus Erythematosus: How QSP Can Support Drug Development & Clinical Trial Design
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that affects more than five million people worldwide.
Best of both worlds: An expansion of the state of the art pKa model with data from three industrial partners
In a unique collaboration between Simulations Plus and several industrial partners, we were able to develop a new version 11.0 of the previously published in silico pKa model, S+pKa, with considerably improved prediction accuracy
Prediction of Disease Progression and Clinical Response in Systemic Sclerosis: Experience From a Proof-of-Concept Trial
Using the modified Rodnan skin score (mRSS) as a surrogate for disease activity, a phase 2a study in patients with systemic sclerosis (SSc) measured efficacy of the autotaxin inhibitor ziritaxestat.
Assessing the Anticholinergic Cognitive Burden Classification of Putative Anticholinergic Drugs Using Drug Properties
This study evaluated the use of machine learning to leverage drug absorption, distribution, metabolism and excretion (ADME) data together with physicochemical and pharmacological data to develop a novel anticholinergic burden scale and compare its performance to previously published scales.
Application of Mechanistic Pharmacokinetic Model for the Optimization of Metformin Delayed Release Dosage Form for Intestinal Targeting
Metformin (MET) is a widely prescribed drug for managing Type 2 Diabetes Mellitus (T2DM). Despite the rich clinical experience and advantages, the clinical utility of MET in renal failure patients is limited because of the treatment-related side effects.
Investigative analysis of blood–brain barrier penetrating potential of electronic nicotine delivery systems (e-cigarettes) chemicals using predictive computational models
Seizures are known potential side effects of nicotine toxicity and have been reported in electronic nicotine delivery systems (ENDS, e-cigarettes) users, with the majority involving youth or young adults.
Simulations Plus to Participate in the Morgan Stanley 3rd Annual Life Sciences AI Summit
Simulations Plus to Participate in the Morgan Stanley 3rd Annual Life Sciences AI Summit
Physiologically-Based Pharmacokinetic Modelling to Investigate the Effect of CYP3A4/3A5 Maturation on Tacrolimus Pharmacokinetics in Paediatric HSCT Patients
Tacrolimus (FK506) is a cornerstone of GVHD-prophylaxis treatment in paediatrics undergoing haematopoietic stem cell transplantation (HSCT).
Simulations Plus Announces Third Quarter Fiscal Year 2024 Earnings and Conference Call Date
Conference call to be on Tuesday, July 2, 2024, at 5 p.m. EDT
The Power of Using a Single PBPK Modeling and Simulation Platform
Physiologically-based pharmacokinetic (PBPK) modeling is now a standard tool used across the pharmaceutical industry to increase understanding of a drug’s behavior in the body and to help guide its development.
Prediction of the Liver Safety Profile of a First-in-Class Myeloperoxidase Inhibitor Using Quantitative Systems Toxicology Modeling
The novel myeloperoxidase inhibitor verdiperstat was developed as a treatment for...
Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI
Integrating Human Biomimetic Liver Microphysiology System with Quantitative Systems Toxicology Modeling to Predict DILI