Drug Safety 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

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

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

On-Demand Webinar

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

Watch this on-demand webinar to learn how model-based meta-analysis (MBMA), quantitative systems pharmacology (QSP), and…

CertaraJanuary 22, 2026

Webinar

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

CertaraJanuary 14, 2026

On-Demand Webinar

Safety First: Uncovering the Clinical Risks Inside Your Compound Screening Data

Learn how to interpret screening assay data to predict clinical off-target risk with ToxStudio® and…

CertaraJanuary 13, 2026

Fact Sheet

Add Off-target Risk Profiling to Your Analyses

Certara's cheminformatics solution, D360, supports a key feature of Secondary Intelligence: a low-medium-high ranking of…

CertaraJanuary 5, 2026

Publication

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

This study synthesizes data from a large body of clinical trials to evaluate rates of…

CertaraDecember 18, 2025

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

Drug Safety

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

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

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

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

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

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

Safety First: Uncovering the Clinical Risks Inside Your Compound Screening Data

Add Off-target Risk Profiling to Your Analyses

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

Merck Advances Pediatric Oncology with Innovative ADC Modeling

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