Model Informed Drug Development Archives

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

Conference

ICoP 2026 India

Danielle PillsburyDecember 11, 2025

Fact Sheet

Expedited Pharmacometrics Regulatory Submissions

Certara delivers complete, compliant pharmacometric regulatory submission packages in just 4–6 weeks, eliminating the PMx…

CertaraDecember 8, 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

Publication

History and Evolution of Innovations in Clinical Pharmacology

This paper reviews how decades of scientific and technological advances have transformed clinical pharmacology and…

Danielle PillsburyNovember 26, 2025

Publication

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

Researchers modeled how amyloid plaques form and clear in Alzheimer’s disease, helping explain how treatments…

CertaraNovember 26, 2025

Guide

10 Strategic Foundations for Early Drug Development

Discover effective Early Drug Development strategies to navigate early development with confidence and clarity. Download…

CertaraNovember 26, 2025

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

Model Informed Drug Development

Merck Advances Pediatric Oncology with Innovative ADC Modeling

ICoP 2026 India

Expedited Pharmacometrics Regulatory Submissions

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

History and Evolution of Innovations in Clinical Pharmacology

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

10 Strategic Foundations for Early 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

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