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…

Certara2025 年 11 月 21 日

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™…

Certara2025 年 11 月 17 日

Blog

Using M&S to Evaluate Oncology Drug Dosing

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

Certara2025 年 11 月 14 日

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,…

Certara2025 年 11 月 13 日

On-Demand Webinar

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

Watch our on-demand webinar on empiric PK time-course scaling and learn how Certara’s translational experts…

Certara2025 年 11 月 13 日

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…

Certara2025 年 11 月 12 日

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 Pillsbury2025 年 11 月 12 日

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…

Certara2025 年 11 月 10 日

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

In today’s market where long development timelines and investor caution can slow progress, MIDD offers…

Certara2025 年 11 月 10 日

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, &…

Certara2025 年 11 月 7 日

模型引导的药物开发