Publication Archives

Publication

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

Danielle Pillsbury2025年6月19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

A translational model-based meta-analysis to predict tremor incidence associated with serotonin reuptake transporter inhibition

The serotonin reuptake transporter (SERT) is responsible for the removal and recycling of the neurotransmitter…

Certara2025年4月30日

Publication

Interactions of Therapeutic Antibodies With Presynaptically-Released Misfolded Proteins in Neurodegenerative Diseases. A Spatial Monte-Carlo Simulation Study

The spatial progression hypothesis of misfolded tau and alpha-synuclein proteins in Alzheimer's and Parkinson's Disease…

Certara2025年4月28日

Publication

IUPHAR review: Computational Psychiatry 2.0. A new tool for supporting combination therapy of psychopharmacology with neuromodulation in schizophrenia

Recent clinical trial successes in schizophrenia with non-dopaminergic agents have rejuvenated the field after a…

Certara2025年4月24日

Publication

HIV感染でウイルス学的に抑制されている思春期患者における、長時間作用型注射剤カボテグラビルと長時間作用型注射剤リルピビリンの併用療法の安全性（IMPAACT 2017/MOCHA）：第1/2相、多施設共同、オープンラベル、非比較、用量設定試験

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

Certara2025年3月20日

Publication

MIDD in Japan – Implementations, challenges and opportunities

In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches…

Certara2025年3月12日

Publication

抗体薬物複合体の市販後評価：モデルに基づくメタ解析（MBMA）および臨床有用性指数アプローチを用いた概念実証

This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…

Certara2025年3月4日

Publication

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

In this paper, we discuss a method to integrate simulated markers of inflammation from a…

Certara2025年2月27日

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…

Certara2025年2月25日

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論文

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

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

A translational model-based meta-analysis to predict tremor incidence associated with serotonin reuptake transporter inhibition

Interactions of Therapeutic Antibodies With Presynaptically-Released Misfolded Proteins in Neurodegenerative Diseases. A Spatial Monte-Carlo Simulation Study

IUPHAR review: Computational Psychiatry 2.0. A new tool for supporting combination therapy of psychopharmacology with neuromodulation in schizophrenia

MIDD in Japan – Implementations, challenges and opportunities

抗体薬物複合体の市販後評価：モデルに基づくメタ解析（MBMA）および臨床有用性指数アプローチを用いた概念実証

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

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