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.
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.
Simulations Plus and Partners Awarded New FDA Grant to Validate In Vitro-In Vivo Extrapolation Methods for Complex Formulations
Collaboration goal to develop alternative methods to assess clinical performance of product variants under different conditions
Mechanistic Representation of Clusterin, a Damage Biomarker for Early Detection of Drug-induced AKI
Novel biomarkers have the potential to address early diagnosis and...
Machine learning driven bioequivalence risk assessment at an early stage of generic drug development
Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development.
Discovery and Characterization of BAY-184: A New Potent and Selective Acylsulfonamide-Benzofuran In Vivo-Active KAT6AB InhibitorCli
KAT6A and KAT6B genes are two closely related lysine acetyltransferases that transfer an acetyl group from acetyl coenzyme A (AcCoA) to lysine residues of target histone substrates, hence playing a key role in chromatin regulation.
Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals
Botanical supplements, herbal remedies, and plant-derived products are used globally. However, botanical dietary supplements are rarely subjected to robust safety testing unless there are adverse reports in post-market surveillance.
Orforglipron Weight Loss and Nausea Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients