Publication Archives

Publication

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics,…

CertaraFebruary 10, 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

Publication

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals

Background Coronavirus disease 2019 (COVID-19) remains a major public health concern, with continued resurgences of…

CertaraJanuary 16, 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

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

Publication

Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

Predicting metabolic drug–drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development,…

CertaraDecember 12, 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

Publication

Quantitative Systems Pharmacology-Based Digital Twins Approach Supplements Clinical Trial Data for Enzyme Replacement Therapies in Pompe Disease

Pompe disease is a rare, progressive neuromuscular disease caused by deficient lysosomal glycogen degradation, and…

CertaraDecember 4, 2024

Publication

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

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

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals

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

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

Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

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

Quantitative Systems Pharmacology-Based Digital Twins Approach Supplements Clinical Trial Data for Enzyme Replacement Therapies in Pompe Disease

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