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,…

Certara2025年2月10日

Publication

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

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

Certara2025年2月6日

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…

Certara2025年1月23日

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…

Certara2025年1月21日

Publication

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

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

Certara2025年1月16日

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…

Certara2025年1月14日

Publication

INTERCEPT-AD：アルツハイマー病による軽度認知障害または軽度認知症の被験者を対象とした、サビルネトゥグ静脈内投与のフェーズ1試験

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

Certara2025年1月8日

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,…

Certara2024年12月12日

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…

Certara2024年12月9日

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…

Certara2024年12月4日

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論文

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

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

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: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

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

INTERCEPT-AD：アルツハイマー病による軽度認知障害または軽度認知症の被験者を対象とした、サビルネトゥグ静脈内投与のフェーズ1試験

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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