Model Informed Drug Development Archives

Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…

CertaraMarch 4, 2025

Blog

How the US FDA MIDD paired pilot program helps sponsors

February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…

CertaraFebruary 28, 2025

Publication

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…

CertaraFebruary 25, 2025

Poster

Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease

CertaraFebruary 7, 2025

Publication

Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies

This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…

CertaraFebruary 6, 2025

Press Coverage

How do you see advances in personalized medicine reshaping patient care, and what are the key challenges and opportunities ahead?

Discover how advances in personalized medicine are reshaping patient care, and why biosimulation will become…

CertaraJanuary 31, 2025

Publication

Understanding Variability in CAR-T Cell Therapy Kinetics

Axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy for relapsed and refractory non-Hodgkin’s lymphoma (NHL), demonstrates…

CertaraJanuary 23, 2025

Publication

Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

The integration of MID3 offers a transformative opportunity for the MENA region to advance pharmaceutical…

CertaraJanuary 14, 2025

On-Demand Webinar

Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA)

In this on-demand webinar, "MBMA: Optimizing Drug Development with Aggregate Clinical Trial Data and Predictive…

CertaraJanuary 9, 2025

On-Demand Webinar

From Research to Real-World Impact: A Model Informed Drug Development (MIDD) Framework to Support Understudied Populations

SVP, Client and Regulatory Strategy, Certara Dr. Karen Rowland Yeo is Senior Vice-President, Client &…

CertaraJanuary 3, 2025

Model Informed Drug Development

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

How the US FDA MIDD paired pilot program helps sponsors

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease

Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies

How do you see advances in personalized medicine reshaping patient care, and what are the key challenges and opportunities ahead?

Understanding Variability in CAR-T Cell Therapy Kinetics

Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA)

From Research to Real-World Impact: A Model Informed Drug Development (MIDD) Framework to Support Understudied Populations

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