Model Informed Drug Development Archives

Guide

How to Leverage PBPK Modeling and Simulation in Drug Research and Development

Learn how PBPK modeling and simulation in drug research and development reduces clinical burden, supports…

CertaraMay 12, 2026

Webinar

Minimize risk when preparing for hepatic impairment studies

CertaraMay 12, 2026

Webinar

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

CertaraMay 8, 2026

Guide

Designing Drug Development Programs for Reimbursement Success

Download the guide to learn how model-informed drug development, QSP, and MBMA help align with…

CertaraMay 7, 2026

Publication

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

A newly approved RNA interference (RNAi) therapy lowers harmful triglyceride (TG) levels in patients with…

CertaraMay 7, 2026

Publication

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

This study evaluated how the leukemia drug ziftomenib behaves in the body and whether different…

CertaraMay 7, 2026

Publication

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…

CertaraMay 7, 2026

Blog

Top 10 Benefits of Simcyp® Simulator for Drug Development

JTVCdGVhbV9qdW1wX2xpc3QlNUQ= April 23, 2026 Physiologically based pharmacokinetic (PBPK) modeling has evolved from an emerging methodology…

CertaraApril 23, 2026

Blog

ADC Dose Optimization: Applying Model-Informed Strategies in Development

Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…

CertaraApril 22, 2026

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

CertaraApril 7, 2026

Model Informed Drug Development

How to Leverage PBPK Modeling and Simulation in Drug Research and Development

Minimize risk when preparing for hepatic impairment studies

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

Designing Drug Development Programs for Reimbursement Success

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Top 10 Benefits of Simcyp® Simulator for Drug Development

ADC Dose Optimization: Applying Model-Informed Strategies in Development

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

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