Biologics Archives

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

Webinar

CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

CertaraJanuary 14, 2026

Case Study

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…

CertaraDecember 12, 2025

Live Events

QSP Workshop 2026 in Japan & Korea – Mastering Scalable AI-enabled QSP modeling software, Certara IQ™

Japan: February 26, 2026 - 1:00 - 5:00 pm | Korea: Wednesday, March 4, 2026…

CertaraDecember 9, 2025

Publication

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

Researchers modeled how amyloid plaques form and clear in Alzheimer’s disease, helping explain how treatments…

CertaraNovember 26, 2025

Biologics

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

CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

Merck Advances Pediatric Oncology with Innovative ADC Modeling

QSP Workshop 2026 in Japan & Korea – Mastering Scalable AI-enabled QSP modeling software, Certara IQ™

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

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