Therapeutic Specialties Archives

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 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

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

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

CertaraJanuary 30, 2026

Publication

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…

CertaraJanuary 22, 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

Announcement

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.

CertaraDecember 3, 2025

Blog

Using M&S to Evaluate Oncology Drug Dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Therapeutic Specialties

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

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

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Using M&S to Evaluate Oncology Drug Dosing

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

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