Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions Blog Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions Explore how PMx regulatory submissions, exposure-response modeling, and strategic pharmacometrics planning support successful and timely…CertaraDecember 29, 2025
Strategic Project Management for Accelerated Drug Development Fact Sheet Strategic Project Management for Accelerated Drug Development Expert project leadership to keep complex programs on track, aligned, and moving forward—so you can…CertaraDecember 23, 2025
Pharma positions itself for 2026 amid an evolving US landscape Press Coverage Pharma positions itself for 2026 amid an evolving US landscape Explore how U.S. policy changes — including tariffs, onshoring, and Most Favored Nation pricing —…CertaraDecember 22, 2025
Alternative parameters in NCA using Phoenix WinNonlin Webinar Alternative parameters in NCA using Phoenix WinNonlin CertaraDecember 22, 2025
A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection Publication A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection This study synthesizes data from a large body of clinical trials to evaluate rates of…CertaraDecember 18, 2025
A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies Publication A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies This tutorial introduces the physiologically inspired PKRO (piPKRO) model - a streamlined, mechanistic framework for…CertaraDecember 18, 2025
First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies Poster First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies Learn how QSP modeling enabled safe, data-driven FIH dose prediction for the trispecific T-cell activator…CertaraDecember 16, 2025
From Unstructured Data to Dose Insights: Applying Modern AI to Exposure Bracketing Webinar From Unstructured Data to Dose Insights: Applying Modern AI to Exposure Bracketing CertaraDecember 16, 2025