Infliximab (IFX), ipilimumab (IPI), and nivolumab (NIVO) have been associated with hepatotoxicity...
Simulated CD8+ T Cell-Mediated Liver Injury During Ipilimumab Administration in a Simulated Population (SimPops®) Demonstrates Profiles Consistent with Observed Clinical Data
Immune checkpoint inhibitors (ICIs) have revolutionized treatment of various cancers. They act by releasing the brakes on immune responses to permit immune-mediated tumor cell killing...
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The recent availability of effective GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients. Understanding the balance between body weight (BW) loss...
Comparison of Sensitivity Analysis Methods in the Context of a QSP Model for Gout
As quantitative systems pharmacology (QSP) models are increasingly used to inform key...
Eculizumab as a Key Comparator for the Evaluation of Complement Targeted Novel Therapeutic Strategies with a QSP Model
Paroxysmal nocturnal hemoglobinuria (PNH) is one of multiple diseases in which complement dysregulation, leading to...
Modeling progression and treatment of prostate cancer using the Thales QSP software platform
Metastatic, castration resistant prostate cancer (mCRPC) is an aggressive form of prostate cancer in...
Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables
Funded collaboration will leverage current FDA partnership to include additional LAI technologies
Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models
This study assessed the pharmacokinetic (PK) interactions between clarithromycin (a P-glycoprotein [P-gp] inhibitor) and four direct oral anticoagulants (DOACs) (P-gp substrates) using physiologically based PK (PBPK) models to elucidate the influence of P-gp in the interaction between them.
Discovery of Penicillic Acid as a Chemical Probe Against Tau Aggregation in Alzheimer’s Disease
Alzheimer's Disease (AD) is a neurodegenerative disorder proven to be caused by the aggregation of protein tau into fibrils, resulting in neuronal death.
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The availability of effective GLP-1 receptor agonists (GLP-1RAs) for obesity treatment has greatly benefited patients. Balancing body weight (BW) loss with nausea is crucial to predict the effectiveness of these medications, along with understanding the impact of delivery methods. Quantitative Systems Pharmacology (QSP) modeling helps predict efficacy and adverse events, assessing key differences and similarities between treatment protocols.
Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation
Trofinetide, the first approved treatment for Rett syndrome (RTT), is primarily excreted unchanged in the urine; therefore, it is important to assess the extent to which the exposure is affected in patients with renal impairment.
Weight Loss and Nausea from Obesity Treatments are Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided...
Simulations Plus to Participate in the Stephens Annual Investment Conference
Simulations Plus to Participate in the Stephens Annual Investment Conference
Liver Safety+ Flyer
The only platform that allows you to predict liver safety during discovery
Hansen parameters and GastroPlus assisted optimized topical elastic liposomes to treat breast cancer using a novel isatin derivative
Breast cancer treatment is a global health challenge using conventional toxic chemotherapeutic agents.
Demonstrating Discriminatory Power of a Dissolution Method Using DDDPlus: Case Study of an ExtendedRelease Formulation and Use in Regulatory Justifications
Dissolution testing is an important attribute that provides insight into in vivo performance, batch-tobatch uniformity and consistent clinical quality.
Identification, Characterization, and in silico ADMET Prediction of Nirmatrelvir and its Degradation Products Using HPLC-PDA and LC-QTOF-MS/MS
Nirmatrelvir is a protease inhibitor that is essential for virus replication. Nirmatrelvir is indicated for the management of mild to severe cases of COVID-19 in individuals who are 12 years of age or older.
What You Need to Know About Using PBPK Modeling for DDI Interaction Assessments for GLP-1 Agonists
GLP-1 agonists have become a crucial component in the treatment of metabolic disorders like type 2 diabetes and obesity.