Search Results - "Terranova, Nadia"
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Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model‐Informed Precision Medicine
Published in Clinical pharmacology and therapeutics (01-04-2024)“…The increasing breadth and depth of resolution in biological and clinical data, including ‐omics and real‐world data, requires advanced analytical techniques…”
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Bridging pharmacology and neural networks: A deep dive into neural ordinary differential equations
Published in CPT: pharmacometrics and systems pharmacology (01-08-2024)“…The advent of machine learning has led to innovative approaches in dealing with clinical data. Among these, Neural Ordinary Differential Equations (Neural…”
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Population pharmacokinetics of ATR inhibitor berzosertib in phase I studies for different cancer types
Published in Cancer chemotherapy and pharmacology (01-02-2021)“…Purpose Berzosertib (formerly M6620) is the first-in-class inhibitor of ataxia–telangiectasia and Rad3-related protein, a key component of the DNA damage…”
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Fast screening of covariates in population models empowered by machine learning
Published in Journal of pharmacokinetics and pharmacodynamics (01-08-2021)“…One of the objectives of Pharmacometry (PMX) population modeling is the identification of significant and clinically relevant relationships between parameters…”
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Population pharmacokinetic model selection assisted by machine learning
Published in Journal of pharmacokinetics and pharmacodynamics (01-04-2022)“…A fit-for-purpose structural and statistical model is the first major requirement in population pharmacometric model development. In this manuscript we discuss…”
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Explainable machine learning prediction of edema adverse events in patients treated with tepotinib
Published in Clinical and translational science (01-09-2024)“…Tepotinib is approved for the treatment of patients with non‐small‐cell lung cancer harboring MET exon 14 skipping alterations. While edema is the most…”
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Model‐informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets
Published in Clinical and translational science (01-02-2022)“…Cladribine tablets have been approved in many countries for the treatment of patients with various forms of relapsing multiple sclerosis (MS). Cladribine has a…”
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Predicting disease activity in patients with multiple sclerosis: An explainable machine‐learning approach in the Mavenclad trials
Published in CPT: pharmacometrics and systems pharmacology (01-07-2022)“…Multiple sclerosis (MS) is among the most common autoimmune disabling neurological conditions of young adults and affects more than 2.3 million people…”
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Asia‐inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler
Published in Clinical and translational science (01-10-2024)“…With the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guidelines in effect from 2018, the…”
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Pharmacometric modeling and machine learning analyses of prognostic and predictive factors in the JAVELIN Gastric 100 phase III trial of avelumab
Published in CPT: pharmacometrics and systems pharmacology (01-03-2022)“…Avelumab (anti–PD‐L1) is an approved anticancer treatment for several indications. The JAVELIN Gastric 100 phase III trial did not meet its primary objective…”
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Assessing Similarity Among Individual Tumor Size Lesion Dynamics: The CICIL Methodology
Published in CPT: pharmacometrics and systems pharmacology (01-04-2018)“…Mathematical models of tumor dynamics generally omit information on individual target lesions (iTLs), and consider the most important variable to be the sum of…”
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Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non‐small cell lung cancer based on bintrafusp alfa trials
Published in CPT: pharmacometrics and systems pharmacology (01-01-2024)“…This analysis aimed to quantify tumor dynamics in patients receiving either bintrafusp alfa (BA) or pembrolizumab, by population pharmacokinetic…”
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Modeling tumor size dynamics based on real‐world electronic health records and image data in advanced melanoma patients receiving immunotherapy
Published in CPT: pharmacometrics and systems pharmacology (01-08-2023)“…The development of immune checkpoint inhibitors (ICIs) has revolutionized cancer therapy but only a fraction of patients benefits from this therapy…”
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The Standard Output: A Tool‐Agnostic Modeling Storage Format
Published in CPT: pharmacometrics and systems pharmacology (01-09-2018)“…The SO is based on a hierarchical structure defined to separate independent output information or results obtained from different modeling tasks (e.g.,…”
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Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities
Published in The AAPS journal (18-05-2021)“…The exponential increase in our ability to harness multi-dimensional biological and clinical data from experimental to real-world settings has transformed…”
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The Clinical Pharmacology of Cladribine Tablets for the Treatment of Relapsing Multiple Sclerosis
Published in Clinical pharmacokinetics (01-03-2019)“…Cladribine Tablets (MAVENCLAD ® ) are used to treat relapsing multiple sclerosis (MS). The recommended dose is 3.5 mg/kg, consisting of 2 annual courses, each…”
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Effects of Postponing Treatment in the Second Year of Cladribine Administration: Clinical Trial Simulation Analysis of Absolute Lymphocyte Counts and Relapse Rate in Patients with Relapsing-Remitting Multiple Sclerosis
Published in Clinical pharmacokinetics (01-03-2019)“…Introduction Cladribine Tablets (MAVENCLAD ® ) selectively reduce absolute lymphocyte counts (ALCs) in patients with multiple sclerosis. The recommended…”
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Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data
Published in Journal of pharmacokinetics and pharmacodynamics (27-08-2024)“…The generation of synthetic patient data that reflect the statistical properties of real data plays a fundamental role in today's world because of its…”
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Artificial Intelligence for Quantitative Modeling in Drug Discovery and Development: An Innovation and Quality Consortium Perspective on Use Cases and Best Practices
Published in Clinical pharmacology and therapeutics (01-04-2024)“…Recent breakthroughs in artificial intelligence (AI) and machine learning (ML) have ushered in a new era of possibilities across various scientific domains…”
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Current Status and Future Directions: The Application of Artificial Intelligence/Machine Learning for Precision Medicine
Published in Clinical pharmacology and therapeutics (01-04-2024)“…Technological innovations, such as artificial intelligence (AI) and machine learning (ML), have the potential to expedite the goal of precision medicine,…”
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