Model Informed Drug Development Archives

On-Demand Webinar

Designing a High-Value Drug Development Program: From Concept to First-in-Human (FIH)

Learn to design drug development programs for First-in-Human (FIH) success with biomarkers, PK/PD modeling, and…

CertaraAugust 29, 2025

On-Demand Webinar

Blueprint for Biotech Success: De-risking Early Development to Secure Long-Term Value

Discover strategies to cut risk, speed timelines, and boost investor confidence in early biotech development.

CertaraAugust 21, 2025

On-Demand Webinar

ToxStudio®: In silico tools to accelerate toxicology assessments

Watch to explore ToxStudio—in silico toxicology platform designed to address key preclinical safety challenges.

CertaraAugust 19, 2025

Conference

BioTechX US 2025

– – Booth

Simona ColucciAugust 15, 2025

Publication

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…

CertaraAugust 13, 2025

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

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

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

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

CertaraAugust 1, 2025

Blog

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

CertaraJuly 31, 2025

Model Informed Drug Development

Designing a High-Value Drug Development Program: From Concept to First-in-Human (FIH)

Blueprint for Biotech Success: De-risking Early Development to Secure Long-Term Value

ToxStudio®: In silico tools to accelerate toxicology assessments

BioTechX US 2025

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

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

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

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

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

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