Publication

Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients

See how a QSP model guided efficacy-proximal FIH dosing for ISB 2001 in the TRIgnite-1…

CertaraJune 4, 2026

Video

Applying AI-Driven Biosimulation to Drug Discovery

Certara President Leif Pedersen explains how PBPK and QSP modeling, proven across 125+ FDA-approved drugs,…

CertaraJune 2, 2026

Publication

Review: application and opportunities for machine learning and artificial intelligence in preclinical immunogenicity risk assessment

This review explores how artificial intelligence (AI), machine learning (ML), and quantitative systems pharmacology (QSP)…

CertaraJune 2, 2026

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

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

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

Publication

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

This article describes how a model-informed drug development (MIDD) approach was used to support the…

CertaraMarch 24, 2026

Blog

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

On-Demand Webinar

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

CertaraFebruary 23, 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

Biologics

Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients

Applying AI-Driven Biosimulation to Drug Discovery

Review: application and opportunities for machine learning and artificial intelligence in preclinical immunogenicity risk assessment

ADC Dose Optimization: Applying Model-Informed Strategies in Development

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

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

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

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