Drug Development Archives

Publication

MIDD in Japan – Implementations, challenges and opportunities

In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches…

CertaraMarch 12, 2025

Video

Behind the Science: A Conversation with Katrina Hui

CertaraMarch 5, 2025

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

Machine Learning for PK/PD Modeling in Drug Development

Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…

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

On-Demand Webinar

Machine Learning for Population PK Model Selection: Theory and Practice

Three of Certara's expert modelers provide a gentle introduction to machine learning in our field.…

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

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

Drug Development

MIDD in Japan – Implementations, challenges and opportunities

Behind the Science: A Conversation with Katrina Hui

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

Machine Learning for PK/PD Modeling in Drug Development

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

Machine Learning for Population PK Model Selection: Theory and Practice

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

Understanding Variability in CAR-T Cell Therapy Kinetics

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