Modeling and Simulation Archives

Blog

ADC Dose Optimization: Applying Model-Informed Strategies in Development

Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…

CertaraApril 22, 2026

On-Demand Webinar

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…

CertaraApril 10, 2026

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

CertaraApril 7, 2026

Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Danielle PillsburyApril 2, 2026

Publication

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…

CertaraMarch 26, 2026

On-Demand Webinar

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

Learn how early-stage biosimulation and mechanistic modeling enable smarter portfolio prioritization before IND-enabling studies. Watch…

CertaraMarch 25, 2026

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

CertaraMarch 25, 2026

Publication

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…

Danielle PillsburyMarch 25, 2026

On-Demand Webinar

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…

CertaraMarch 25, 2026

Blog

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…

CertaraMarch 24, 2026

Modeling and Simulation

ADC Dose Optimization: Applying Model-Informed Strategies in Development

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

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

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

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