Model Informed Drug Development Archives

Publication

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

The paper reviews current applications of pediatric PBPK across therapeutic areas and outlines where PBPK…

CertaraNovember 21, 2025

Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

The FDA is phasing out animal testing of new drugs. Learn how Certara’s Non-Animal Navigator™…

CertaraNovember 17, 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

Blog

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

At ACoP 2025, Certara showcased innovation with the launch of Certara IQ™ and Phoenix® Cloud,…

CertaraNovember 13, 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

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

Guide

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Learn how Early Feasibility Assessment and QSP modeling improve drug design, de-risk feasibility studies, &…

CertaraNovember 7, 2025

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

CertaraNovember 5, 2025

Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Danielle PillsburyNovember 3, 2025

Model Informed Drug Development

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

Using M&S to Evaluate Oncology Drug Dosing

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

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

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

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