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Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders

Orphanet journal of rare diseases, 2019-02, Vol.14 (1), p.36-36, Article 36

2019

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Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches

International journal of infectious diseases, 2017-03, Vol.56 (C), p.208-211

2017

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Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts

BMC infectious diseases, 2022-04, Vol.22 (1), p.327-327, Article 327

2022

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Total Kidney Volume Is a Prognostic Biomarker of Renal Function Decline and Progression to End-Stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease

Kidney international reports, 2017-05, Vol.2 (3), p.442-450

2017

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Accelerating healthcare innovation: the role of Artificial intelligence and digital health technologies in critical path institute’s public‐private partnerships

Clinical and translational science, 2024-06, Vol.17 (6), p.e13851-n/a

2024

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Landscape analysis for a neonatal disease progression model of bronchopulmonary dysplasia: Leveraging clinical trial experience and real-world data

Frontiers in pharmacology, 2022-10, Vol.13, p.988974-988974

2022

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Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs

CPT: pharmacometrics and systems pharmacology, 2021-11, Vol.10 (11), p.1382-1395

2021

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Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation

Clinical and translational science, 2023-09, Vol.16 (9), p.1680-1690

2023

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Type 1 diabetes prevention clinical trial simulator: Case reports of model‐informed drug development tool

CPT: pharmacometrics and systems pharmacology, 2024-08, Vol.13 (8), p.1309-1316

2024

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Open Data Revolution in Clinical Research: Opportunities and Challenges

Clinical and translational science, 2020-07, Vol.13 (4), p.665-674

2020

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Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies

CPT: pharmacometrics and systems pharmacology, 2023-07, Vol.12 (7), p.1016-1028

2023

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Standardized Data Structures in Rare Diseases: CDISC User Guides for Duchenne Muscular Dystrophy and Huntington’s Disease

Clinical and translational science, 2021-01, Vol.14 (1), p.214-221

2021

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Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials

Frontiers in neurology, 2021-10, Vol.12, p.712565-712565

2021

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Placebo effect in subjects with cognitive impairment

International review of neurobiology, 2020, Vol.153, p.213-230

2020

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Elements for Adequate Informed Consent in the Surgical Context

World journal of surgery, 2014-07, Vol.38 (7), p.1594-1604

2014

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A Drug Development Tool for Trial Enrichment in Patients With Autosomal Dominant Polycystic Kidney Disease

Kidney international reports, 2017-05, Vol.2 (3), p.451-460

2017

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Evaluation of Warfarin Drug Interaction Listings in US Product Information for Warfarin and Interacting Drugs

Clinical therapeutics, 2011, Vol.33 (1), p.36-45

2011

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CredibleMeds.org: What does it offer?

Trends in cardiovascular medicine, 2018-02, Vol.28 (2), p.94-99

2018

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Pharmacometrics as a Discipline Is Entering the "Industrialization" Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success

Journal of clinical pharmacology, 2010-09, Vol.50 (S9), p.9S-19S

2010

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Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes

Clinical infectious diseases, 2015-08, Vol.61 (suppl 1), p.S25-S31

2015

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A biological classification of Huntington's disease: the Integrated Staging System

Lancet neurology, 2022-07, Vol.21 (7), p.632-644

2022

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Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool

Clinical infectious diseases, 2015-08, Vol.61, p.S5-S9

2015

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Nonclinical Models for Antituberculosis Drug Development: A Landscape Analysis

The Journal of infectious diseases, 2015-06, Vol.211 (suppl 3), p.S83-S95

2015

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Apolipoprotein E Genotype and Sex Risk Factors for Alzheimer Disease: A Meta-analysis

JAMA neurology, 2017-10, Vol.74 (10), p.1178

2017

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Unlocking the Capabilities of Large Language Models for Accelerating Drug Development

Clinical pharmacology and therapeutics, 2024-07, Vol.116 (1), p.38-41

2024

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Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders

Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches

Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts

Total Kidney Volume Is a Prognostic Biomarker of Renal Function Decline and Progression to End-Stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease

Accelerating healthcare innovation: the role of Artificial intelligence and digital health technologies in critical path institute’s public‐private partnerships

Landscape analysis for a neonatal disease progression model of bronchopulmonary dysplasia: Leveraging clinical trial experience and real-world data

Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs

Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation

Type 1 diabetes prevention clinical trial simulator: Case reports of model‐informed drug development tool

Open Data Revolution in Clinical Research: Opportunities and Challenges

Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies

Standardized Data Structures in Rare Diseases: CDISC User Guides for Duchenne Muscular Dystrophy and Huntington’s Disease

Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials

Placebo effect in subjects with cognitive impairment

Elements for Adequate Informed Consent in the Surgical Context

A Drug Development Tool for Trial Enrichment in Patients With Autosomal Dominant Polycystic Kidney Disease

Evaluation of Warfarin Drug Interaction Listings in US Product Information for Warfarin and Interacting Drugs

CredibleMeds.org: What does it offer?

Pharmacometrics as a Discipline Is Entering the "Industrialization" Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success

Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes

A biological classification of Huntington's disease: the Integrated Staging System

Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool

Nonclinical Models for Antituberculosis Drug Development: A Landscape Analysis

Apolipoprotein E Genotype and Sex Risk Factors for Alzheimer Disease: A Meta-analysis

Unlocking the Capabilities of Large Language Models for Accelerating Drug Development

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