Page 11 | Certara

Publication

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…

CertaraAugust 13, 2025

On-Demand Webinar

Differences between eCTD 4.0 and eCTD 3.2.2 Submissions – What You Need to Know

Access our on-demand webinar to explore the key differences between eCTD 4.0 and eCTD 3.2.2.…

CertaraAugust 11, 2025

Blog

Regulatory Operations Best Practices for Health Canada Submissions

Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…

CertaraAugust 11, 2025

Announcement

Certara Announces D360 25.5 Release, Featuring Dynamic Data Subsets and Enhanced Analytics

D360 v25.5 allows scientists to divide up a dataset into series of compounds & perform…

CertaraAugust 7, 2025

Press Release

Certara Reports Second Quarter 2025 Financial Results

RADNOR, PA— August 6, 2025-- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development,…

CertaraAugust 6, 2025

Blog

Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

CertaraAugust 6, 2025

Press Coverage

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

Explore insights from Certara experts on how PK/PD modeling streamlines biologic drug development.

CertaraAugust 5, 2025

On-Demand Webinar

De-risking DDI Management during Clinical Trials: Introducing DIDB’s Concomitant Meds Navigator

Watch the on-demand presentation covering how the DIDB® Concomitant Meds Navigator empowers clinical development teams…

CertaraAugust 5, 2025

Blog

Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

The Simcyp Simulator receives EMA qualification—the first and only PBPK platform formally qualified for any…

CertaraAugust 5, 2025

On-Demand Webinar

Mechanistic Models at the Regulatory Frontier: Insights from EMA’s Qualification of the Simcyp® Simulator

The European Medicines Agency (EMA) formally qualified Certara’s Simcyp® Simulator, marking the first and only…

CertaraAugust 4, 2025

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Differences between eCTD 4.0 and eCTD 3.2.2 Submissions – What You Need to Know

Regulatory Operations Best Practices for Health Canada Submissions

Certara Announces D360 25.5 Release, Featuring Dynamic Data Subsets and Enhanced Analytics

Certara Reports Second Quarter 2025 Financial Results

Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

De-risking DDI Management during Clinical Trials: Introducing DIDB’s Concomitant Meds Navigator

Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

Mechanistic Models at the Regulatory Frontier: Insights from EMA’s Qualification of the Simcyp® Simulator

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