Biologics Archives

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

Blog

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…

CertaraOctober 24, 2025

Video

Highlights from the FDA Guidance on Dosage Optimization for Therapeutic Radiopharmaceuticals

Learn how radiopharmaceutical therapies work in oncology and how Certara supports development with modeling, simulation,…

CertaraOctober 3, 2025

Conference

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

CertaraSeptember 22, 2025

Biologics