Drug Development Archives

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

Poster

Population Pharmacokinetics (PopPK) of Revumenib in Patients with Relapsed/Refractory Acute Leukemias

CertaraDecember 12, 2024

Video

Piet van der Graaf on AI and AI-assisted approaches in drug discovery & development

At the 2024 AAPS PharmSci 360 conference, Bioanalysis Zone interviewed Piet van der Graaf, Senior…

CertaraDecember 10, 2024

Publication

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…

CertaraDecember 9, 2024

Poster

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi

CertaraNovember 22, 2024

Drug Development

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

Population Pharmacokinetics (PopPK) of Revumenib in Patients with Relapsed/Refractory Acute Leukemias

Piet van der Graaf on AI and AI-assisted approaches in drug discovery & development

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi

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