Publication

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

A newly approved RNA interference (RNAi) therapy lowers harmful triglyceride (TG) levels in patients with…

Certara2026年5月7日

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

Certara2026年3月25日

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

Certara2025年11月5日

White Paper

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

Replace or waive TQT studies with validated C-QT analysis strategies accepted by FDA, EMA, PMDA.…

Certara2025年10月3日

Announcement

新製品Libra™：AIを活用した薬物誘発性肝障害予測ツール

RADNOR, Pa. – 2025年9月17日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in…

Certara2025年9月17日

Blog

Replacing traditional TQT studies with model-based concentration-qtc (C-qtc) analysis for cardiovascular safety in drug development

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

Certara2025年8月6日

Publication

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…

Certara2025年6月8日

Publication

Impact of Target-mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

Certara2016年11月15日

White Paper

モデルに基づくメタ解析（MBMA）：革新的な手法の誕生

MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…

Certara2016年7月14日

Publication

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

Certara2016年3月1日

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心血管系疾患

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

新製品Libra™：AIを活用した薬物誘発性肝障害予測ツール

Replacing traditional TQT studies with model-based concentration-qtc (C-qtc) analysis for cardiovascular safety in drug development

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

Impact of Target-mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

モデルに基づくメタ解析（MBMA）：革新的な手法の誕生

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

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