The question is not whether agentic AI is coming. It is this: can you stake a regulatory submission on it?
Quantitative Systems Toxicology Model Predicts Obeticholic Acid-Associated Liver Injury in Metabolic Dysfunction-Associated Steatotic Liver Disease
Obeticholic acid (OCA), a synthetic analog of chenodeoxycholic acid, was approved in 2016 for the treatment of primary biliary cholangitis.
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).
GastroPlus in Model-informed Drug Development: PBPK Modelling, ACAT Modelling, and Regulatory Relevance
GastroPlus is a popular mid-21st century modeling software used in the drug development world to simulate in vivo drug behaviours based on in vitro and physicochemical data.
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?
Enrichment, Response Amplification, Separation, and Inclusion: Quantifying Trial Design Trade-offs in SLE with QSP SimPops Modeling
Systemic lupus erythematosus (SLE) trials suffer from equivocal or failed trial outcomes.
Pulmonary Physiological-Based Pharmacokinetic (PBPK) Modeling for Clinical Systemic and Regional PK Prediction of Inhaled Nintedanib Drug Products
Nintedanib (Nint), a tyrosine kinase inhibitor, is approved by the FDA for the treatment of idiopathic pulmonary fibrosis (IPF) by administration as an oral tablet.
Mechanistic PBPK Modeling Identifies Oral Microenvironment Determinants of Buccal Midazolam Exposure
Buccal drug delivery relies on prolonged mucosal contact for absorption, sensitive to interindividual chemical and physical variability within the oral microenvironment (Hua, 2019; Shipp et al., 2022).
GP Metabolism & Transporter Module Flyer
Extend your mechanistic modeling to fully utilize your in vitro data and model complex scenarios.
Simulations Plus and NVIDIA Collaborate to Scale GPU-Accelerated, AI-Assisted Modeling Workflows
Combines validated scientific engines with accelerated computing and AI to enable more scalable, integrated modeling workflows across the drug development lifecycle