Drug discovery remains constrained by high attrition rates and the fragmented evaluation of exposure, efficacy, and safety.
Why Mechanistic Modeling has Become the Preferred Framework for Modern Generic Development
When the question is mechanism, deconvolution estimates. PBBM explains.
Animal-Free Skin Sensitization Testing: In Chemico and In Silico Integrated Approach
The increasing prohibition of animal testing for cosmetic products has driven the development of alternative approaches to ensure consumer safety.
In vitro Drug-Like Properties Evaluation of the New Positive Allosteric Modulators of EAAT2 Glutamate Transporter
Evaluation of drug-like properties in vitro is critical in identifying viable candidates for new central nervous system (CNS) drugs.
Physiologically Based Pharmacokinetic and Drug–Drug Interaction Modeling of Efavirenz, Etravirine, and Saquinavir in Prostate Cancer
Prostate cancer remains one of the most prevalent malignancies worldwide, with high mortality in advanced and metastatic stages.
Simulations Plus Advances Agentic Drug Development with NVIDIA BioNeMo Agent Toolkit
New capabilities connect AI agents, scientific literature, and validated computational engines to accelerate model-informed drug development
Keeping Pace with Obesity Drug Development: Recent Advances in OBESITYsym®
In this webinar, Dr. Scott Q. Siler, Chief Science Officer of QSP, discusses how quantitative systems pharmacology can help improve the efficiency of obesity drug development.
The Scientist, Amplified: Why Agentic Drug Development Needs a Foundation It Can Trust
The question is not whether agentic AI is coming. It is this: can you stake a regulatory submission on it?
Sex-Related Differences in Physiologically-Based Biopharmaceutics Modeling
Physiologically based pharmacokinetic (PBPK) and physiologically-based biopharmaceutics (PBBM) modeling are valuable tools in drug development, allowing mechanistic predictions of drug absorption and disposition.
Simulations Plus to Be Acquired by Altaris For Approximately $375 Million
Stockholders to Receive $18.50 Per Share in Cash Representing a 26% Premium to 60-day Volume-Weighted Average Price
Transaction to Strengthen Simulations Plus and Accelerate Growth Through Anticipated Combination with Chemical Computing Group
When Does Model Interpretability Matter Most?
Model interpretability is not uniformly critical across all stages of model development; however, it becomes essential at key decision points where scientific understanding must support regulatory confidence.
Integrated Population Pharmacokinetic and Exposure-Response Modeling of Enlicitide in Hypercholesterolemia Patients Supports Clinical Dose Recommendation Across Patient Subgroups
Despite the well-established cardiovascular benefit of low-density lipoprotein cholesterol (LDL-C) lowering, real-world use of PCSK9-targeted therapies remains limited, in part due to reliance on injectable formulations.
2025 AAPS 360 Annual Meeting: Highlights in In Vitro Release and Dissolution Testing and Oral Biopharmaceutics Modeling
This manuscript highlights key sessions from the In Vitro Release and Dissolution Testing (IVRDT) and Oral Biopharmaceutics and Absorption Modeling (OBAM) communities at the 2025 AAPS PharmSci 360 Annual Meeting (November 9–12, San Antonio, TX).
GP AssessmentsPlus™ Flyer
The AssessmentsPlus module in GastroPlus provides structured, expert-guided evaluation of your PBPK and PBBM models.
Project Optimus: Oncology Dose Optimization Based on Clinical Pharmacology Strategy and MIDD Approach
Since the FDA initiated Project Optimus, considerable effort has been stimulated to better select doses of new oncology products.
Why Model Transparency Matters in Regulatory Decision-Making
In high-stakes decision-making, particularly within regulatory submissions to agencies such as the FDA, PMDA, EMA, Health Canada, MHRA, ANVISA, models serve as a weight of evidence approach rather than exploratory tools.
Model-Based Virtual Clinical Trial Reveals Renal Impairment and Body Size as Key Determinants of Pharmacokinetic Variability and Drug-Drug Interaction Risk in Propranolol Therapy
Propranolol (PROP) is a non-selective β-blocker widely prescribed for cardiovascular and neurological disorders.
Impact of Preclinical Verification in Physiologically Based Pharmacokinetic Modelling for First-in-Human Predictions: Application of a Published Model Building Strategy for Five Compounds
Physiologically based pharmacokinetic modelling is routinely used in the pharmaceutical industry and has an impact on drug labels.
Simulations Plus to Participate in the 23rd Annual Craig-Hallum Institutional Investor Conference
Simulations Plus will be participating in the 23rd Annual Craig-Hallum Institutional Investor Conference.
QSP Flex Flyer
Which QSP model option is right for you?