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 PillsburyJune 19, 2025

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,…

CertaraJune 8, 2025

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…

CertaraApril 30, 2025

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…

CertaraApril 28, 2025

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…

CertaraApril 24, 2025

Publication

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

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

CertaraMarch 20, 2025

Publication

MIDD in Japan – Implementations, challenges and opportunities

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

CertaraMarch 12, 2025

Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

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

CertaraMarch 4, 2025

Publication

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

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

CertaraFebruary 27, 2025

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…

CertaraFebruary 25, 2025

Publication

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

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

MIDD in Japan – Implementations, challenges and opportunities

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

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

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