Drug Development Archives

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

Publication

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

This Frontiers in Pharmacology article investigates how using different time-averaged exposure metrics, specifically the time-averaged…

CertaraJanuary 21, 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

Publication

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs),…

CertaraJanuary 8, 2025

Drug Development

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

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

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

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

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