Modeling and Simulation Archives

Blog

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

CertaraFebruary 18, 2026

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

CertaraFebruary 13, 2026

Blog

Pediatric Drug Development: From “Wild West” to Model-Informed Confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

CertaraFebruary 11, 2026

Blog

QSP in Inflammatory Bowel Disease (IBD): From Biomarkers to Clinical Endpoints, with Virtual Patients

Certara supports IBD drug development with a QSP model that predicts Mayo score and CDAI…

CertaraFebruary 10, 2026

Publication

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…

CertaraFebruary 2, 2026

Webinar

Portfolio Prioritization for Large and Small Pharma Using Early-Stage Biosimulation

CertaraJanuary 29, 2026

Conference

Quantitative Systems Pharmacology Conference

CertaraJanuary 26, 2026

Blog

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

Learn how Model-Informed Drug Development strengthens drug asset valuation by reducing uncertainty, predicting clinical performance,…

CertaraJanuary 26, 2026

Publication

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…

CertaraJanuary 22, 2026

Webinar

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

CertaraJanuary 22, 2026

Modeling and Simulation

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Pediatric Drug Development: From “Wild West” to Model-Informed Confidence

QSP in Inflammatory Bowel Disease (IBD): From Biomarkers to Clinical Endpoints, with Virtual Patients

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

Portfolio Prioritization for Large and Small Pharma Using Early-Stage Biosimulation

Quantitative Systems Pharmacology Conference

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

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