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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Therapeutic innovation & regulatory science, 2020-03, Vol.54 (2), p.324-341

2020

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Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

Therapeutic innovation & regulatory science, 2024-05, Vol.58 (3), p.519-519

2024

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Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

Therapeutic innovation & regulatory science, 2024-05, Vol.58 (3), p.415-422

2024

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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Therapeutic innovation & regulatory science, 2020-03, Vol.54 (2), p.370-384

2020

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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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Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder：a three-month observational study

Chinese medical journal, 2010-08, Vol.123 (15), p.2063-2069

2010

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A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials

Clinical pharmacology and therapeutics, 2022-05, Vol.111 (5), p.1050-1060

2022

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Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2015-04, Vol.29 (2), p.123-131

2015

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Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics

Contemporary clinical trials, 2023-09, Vol.132, p.107292-107292, Article 107292

2023

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A Comparison of Proposed Biosimilar LA‐EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early‐Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT‐2), a Phase III, Randomized, Double‐Blind Trial

The oncologist (Dayton, Ohio), 2016-07, Vol.21 (7), p.789-794

2016

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Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance

Transfusion (Philadelphia, Pa.), 2016-12, Vol.56 (12), p.3055-3064

2016

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Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Future oncology (London, England), 2016-06, Vol.12 (11), p.1359-1367

2016

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Association between Painful Physical Symptoms and Clinical Outcomes in Korean Patients with Major Depressive Disorder: A Three-Month Observational Study

PSYCHIATRY INVESTIGATION, 2009, 6(4), , pp.255-263

2009

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Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.e14089-e14089

2016

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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Therapeutic innovation & regulatory science, 2019-04, p.216847901983882

2019

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Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects

Clinical drug investigation, 2015-08, Vol.35 (8), p.495-503

2015

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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Therapeutic innovation & regulatory science, 2019-04, p.216847901984131

2019

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Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study

Expert opinion on pharmacotherapy, 2015-05, Vol.16 (7), p.961-970

2015

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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Therapeutic innovation & regulatory science, 2019-04, p.2168479019841316

2019

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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Therapeutic innovation & regulatory science, 2019-04, p.2168479019838827

2019

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Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study

BMC neurology, 2015-02, Vol.15 (1), p.17-17, Article 17

2015

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Factors associated with weight gain during olanzapine treatment in patients with schizophrenia or bipolar disorder: Results from a six-month prospective, multinational, observational study

The world journal of biological psychiatry, 2009, Vol.10 (4_3), p.729-740

2009

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Abstract 4172: Identification of a low PTEN / high PI3Kα expressing subset of squamous non-small-cell lung cancer (NSCLC)

Cancer research (Chicago, Ill.), 2012-04, Vol.72 (8_Supplement), p.4172-4172

2012

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Academic outcomes in Asian children aged 8-11 years with attention-deficit/hyperactivity disorder treated with atomoxetine hydrochloride

International journal of psychiatry in clinical practice, 2011-06, Vol.15 (2), p.145-156

2011

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Association between painful physical symptoms and clinical outcomes in Taiwanese patients with major depressive disorder: A three-month observational study

Asia-Pacific psychiatry, 2010-10, Vol.2 (3), p.136-145

2010

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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Design and Execution of Sustainable Decentralized Clinical Trials

Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder：a three-month observational study

A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials

Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics

Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics

Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance

Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Association between Painful Physical Symptoms and Clinical Outcomes in Korean Patients with Major Depressive Disorder: A Three-Month Observational Study

Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study

Factors associated with weight gain during olanzapine treatment in patients with schizophrenia or bipolar disorder: Results from a six-month prospective, multinational, observational study

Abstract 4172: Identification of a low PTEN / high PI3Kα expressing subset of squamous non-small-cell lung cancer (NSCLC)

Academic outcomes in Asian children aged 8-11 years with attention-deficit/hyperactivity disorder treated with atomoxetine hydrochloride

Association between painful physical symptoms and clinical outcomes in Taiwanese patients with major depressive disorder: A three-month observational study

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