There’s no one “right” modeling or simulation approach—but some are better suited to answer or explore specific types of questions.
You Don’t Have to Trust an AI Agent Blindly
How Composer keeps AI-enabled MIDD workflows scientific and under your control
QSP Modeling to Support Development of Ziftomenib Combinations in Acute Myeloid Leukemia
Ziftomenib is a potent, selective, oral menin inhibitor that is U.S. FDA-approved as monotherapy at 600mg QD for adults with relapsed/refractory (R/R) NPM1-m AML and no other satisfactory treatments.
PBPK in Drug Development and Regulatory Decision-Making: Past, Present, and Future
The Journey of PBPK M&S Applications in Drug Development and Regulatory Submissions
Physiologically based Biopharmaceutics Modeling (PBBM) Reveals a Low Dissolution-related Bioequivalence Risk for Immediate-Release Amlodipine Tablets
A conservative BCS class III classification was recently proposed for amlodipine based on inconclusive permeability evidence.
Complementing QSP with Machine Learning to Predict IGA-Based Population Response in an Atopic Dermatitis Model
Atopic Dermatitis (AD) is a chronic skin condition characterized by inflammation, itching, and redness. AD is an active area of drug development, with 120+ drug candidates in various stages of pre-clinical and clinical development[1].
A Validation Framework for AI-Based Scientific Tools in Monolixsuite
AI tools are increasingly common in pharmacometrics, with the potential to support routine tasks and make complex workflows more efficient.
Guided Agentic Workflows for Pharmacometric Modeling Using MonolixSuite
Agentic AI can substantially accelerate pharmacometric modeling and simulation, yet its adoption depends on scientific rigor, transparency, and reproducibility.
Simulations Plus Announces Funded Partnership with Global Pharmaceutical Company to Advance AI-Enabled QSP Model Development with Turin
Collaboration will apply Turin to explore mechanistic QSP model structures at scale and bring insights to development decisions where traditional modeling timelines have limited their use
AI in MIDD: From Hype to Practical Application
Everyone wants to incorporate AI into model-informed drug development (MIDD), but the open question is how to do so while maintaining scientific rigor, transparency, and regulatory confidence.
Simulations Plus Announces Completion of Acquisition by Altaris
The transaction was originally announced on June 16, 2026. At the effective time of the merger each Simulations Plus shareholder received $18.50 in cash per share. As a result of the completion of the transaction, Simulations Plus has become a privately held company, and its common stock will no longer trade on the Nasdaq Global Select Market.
Importance of Early Model Development and Data Strategy
Regulatory perspectives increasingly emphasize the value of integrating modeling early in the drug development process rather than applying it retrospectively.
Dose Optimization of Cefazolin for Pediatric Patients with Renal Impairment Using Physiologically Based Pharmacokinetic Modeling (PBPK) in GastroPlus
Cefazolin is a first-generation cephalosporin antibiotic widely used for the treatment and prophylaxis of bacterial infections in both adult and pediatric populations.
Physiologically Based Pharmacokinetic Modelling and Dose Optimization of Tedizolid in Paediatric Patients
Tedizolid is a next-generation oxazolidinone antibiotic approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Understanding Pharmacokinetic Variability of Pomalidomide: A Physiologically Based Pharmacokinetic Analysis of Disease-Related Physiology, Ethnicity, Hepatic Impairment, Food Effects, Drug Interactions, and Smoking
Understanding interindividual pharmacokinetic variability and potential for drug interactions is of clinical importance for pomalidomide given its long-term use in patients with relapsed and/or refractory multiple myeloma (RRMM).
Navigating Surfactant Selection in In Vitro Dissolution Testing: Mechanistic Insights and Practical Strategies
In vitro dissolution testing is central to pharmaceutical development, yet it is increasingly challenged by poorly soluble drugs, which account for over 40% of marketed products and up to 90% of new chemical entities, for which dissolution often limits absorption.
Scientists Must Lead the AI Revolution, Not Follow It
One of the more common narratives surrounding AI is the idea that automation will gradually reduce the importance of scientists and technical experts. Personally, I believe the opposite is true.
ADMET Predictor® 14: Expanded bRo5, HTPK, and AI Capabilities
Drug discovery is maturing. Researchers are increasingly focusing on challenging targets, including beyond Rule of 5 (bRo5) compounds, to achieve previously intractable therapeutic opportunities.
Scientific Engines and Regulatory Trust Must Sit at the Center of AI
AI is the buzzword across every industry right now, and the pharma industry is not immune.
Application of Predictive Modeling in the Development of Amorphous Solid Dispersions
Effective modeling and simulation can reduce physical experimental requirements, ASD development risks, and time to market.