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Advancing innovative clinical trials to efficiently deliver medicines to patients

Nature reviews. Drug discovery, 2022-08, Vol.21 (8), p.543-544

2022

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Bayesian Applications in Pharmaceutical Development

1st, 2020

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Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease

Alzheimer's & dementia : translational research & clinical interventions, 2021, Vol.7 (1), p.e12112-n/a

2021

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Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development

Therapeutic innovation & regulatory science, 2023-05, Vol.57 (3), p.417-425

2023

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Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers

Therapeutic innovation & regulatory science, 2023-05, Vol.57 (3), p.426-435

2023

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Decision making in clinical trials: Interim analyses, innovative design, and biomarkers

Alzheimer's & dementia : translational research & clinical interventions, 2023-10, Vol.9 (4), p.e12421-n/a

2023

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Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy chinese and white volunteers: An open-label trial

Clinical therapeutics, 2010-02, Vol.32 (2), p.365-379

2010

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Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer

Systematic reviews, 2014-09, Vol.3 (1), p.102-102, Article 102

2014

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Design and Execution of Sustainable Decentralized Clinical Trials

Clinical pharmacology and therapeutics, 2023-10, Vol.114 (4), p.802-809

2023

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Evaluation of the performance of alternative models in analyzing longitudinal data for Alzheimer clinical trials compared to MMRM

Alzheimer's & dementia, 2022-12, Vol.18 (S10), p.n/a

2022

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Phase II (NAVIGATE-AD study) Results of LY3202626 Effects on Patients with Mild Alzheimer’s Disease Dementia

JAD reports, 2021-04, Vol.5 (1), p.321-336

2021

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Bayesian methods for the design and analysis of noninferiority trials

Journal of biopharmaceutical statistics, 2016-09, Vol.26 (5), p.823-841

2016

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P3‐026: IMPLEMENTATION OF DUAL‐PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE‐AD CLINICAL TRIAL

Alzheimer's & dementia, 2019-07, Vol.15 (7S_Part_18), p.P935-P935

2019

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P1‐048: PLASMA NF‐L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE‐AD STUDY

Alzheimer's & dementia, 2019-07, Vol.15 (7S_Part_4), p.P251-P251

2019

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PLASMA NF-L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE-AD STUDY

Alzheimer's & dementia, 2019-07, Vol.15 (7), p.P251-P251

2019

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IMPLEMENTATION OF DUAL-PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE-AD CLINICAL TRIAL

Alzheimer's & dementia, 2019-07, Vol.15 (7), p.P935-P935

2019

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Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics

Statistics in biopharmaceutical research, 2022-01, Vol.14 (1), p.5-21

2022

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A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme: Human/Human trials: Anti‐tau

Alzheimer's & dementia, 2020-12, Vol.16 (S9)

2020

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Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme: Translation from rat to human

Alzheimer's & dementia, 2020-12, Vol.16, p.n/a

2020

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A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme

Alzheimer's & dementia, 2020-12, Vol.16, p.n/a

2020

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First-line treatment of patients with advanced or metastatic squamous non-small cell lung cancer: systematic review and network meta-analysis

Journal of thoracic disease, 2018-12, Vol.10 (12), p.6677-6694

2018

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Pharmacokinetics and pharmacodynamics following maintenance doses of prasugrel and clopidogrel in Chinese carriers of CYP2C19 variants

British journal of clinical pharmacology, 2012-01, Vol.73 (1), p.93-105

2012

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Estimation of the inter- and intrasubject variability of the diurnal serum cortisol rhythm in healthy male subjects to evaluate the biomarker potential for drug target engagement

International journal of clinical pharmacology and therapeutics, 2015-03, Vol.53 (3), p.199-205

2015

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Advancing innovative clinical trials to efficiently deliver medicines to patients

Bayesian Applications in Pharmaceutical Development

Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease

Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development

Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers

Decision making in clinical trials: Interim analyses, innovative design, and biomarkers

Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy chinese and white volunteers: An open-label trial

Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer

Design and Execution of Sustainable Decentralized Clinical Trials

Evaluation of the performance of alternative models in analyzing longitudinal data for Alzheimer clinical trials compared to MMRM

MEDI1814 selectively reduces free Aβ42 in cerebrospinal fluid of non-clinical species and Alzheimer's disease patients

Phase II (NAVIGATE-AD study) Results of LY3202626 Effects on Patients with Mild Alzheimer’s Disease Dementia

Bayesian methods for the design and analysis of noninferiority trials

P3‐026: IMPLEMENTATION OF DUAL‐PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE‐AD CLINICAL TRIAL

P1‐048: PLASMA NF‐L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE‐AD STUDY

PLASMA NF-L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE-AD STUDY

IMPLEMENTATION OF DUAL-PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE-AD CLINICAL TRIAL

Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics

A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme: Human/Human trials: Anti‐tau

Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme: Translation from rat to human: Neuroimaging / evaluating treatments

Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme: Translation from rat to human

A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme

First-line treatment of patients with advanced or metastatic squamous non-small cell lung cancer: systematic review and network meta-analysis

Pharmacokinetics and pharmacodynamics following maintenance doses of prasugrel and clopidogrel in Chinese carriers of CYP2C19 variants

Estimation of the inter- and intrasubject variability of the diurnal serum cortisol rhythm in healthy male subjects to evaluate the biomarker potential for drug target engagement

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