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Beyond exposure‐response: A tutorial on statistical considerations in dose‐ranging studies

Clinical and translational science, 2021-07, Vol.14 (4), p.1250-1258

2021

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A Phase I Study of Intravenous LBH589, a Novel Cinnamic Hydroxamic Acid Analogue Histone Deacetylase Inhibitor, in Patients with Refractory Hematologic Malignancies

Clinical cancer research, 2006-08, Vol.12 (15), p.4628-4635

2006

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A Bayesian phase II proof‐of‐concept design for clinical trials with longitudinal endpoints

Statistics in medicine, 2024-01, Vol.43 (1), p.173-183

2024

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Goodness-of-fit test for proportional subdistribution hazards model

Statistics in medicine, 2013-09, Vol.32 (22), p.3804-3811

2013

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Adaptive hybrid control design for comparative clinical trials with historical control data

Journal of the Royal Statistical Society Series C: Applied Statistics, 2024-03, Vol.73 (2), p.444-459

2024

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Design and analysis of drop-the-losers studies using binary endpoints in the rare disease setting

Journal of biopharmaceutical statistics, 2021-07, Vol.31 (4), p.507-522

2021

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A confirmatory basket design considering non-inferiority and superiority testing

Journal of biopharmaceutical statistics, 2024-03, Vol.34 (2), p.205-221

2024

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Burden of cystic fibrosis in children <12 years of age prior to the introduction of CFTR modulator therapies

BMJ open respiratory research, 2021-12, Vol.8 (1), p.e000998

2021

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Burden of cystic fibrosis in children

BMJ open respiratory research, 2021-12, Vol.8 (1)

2021

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Bayesian additive decision trees of biomarker by treatment interactions for predictive biomarker detection and subgroup identification

Journal of biopharmaceutical statistics, 2018-05, Vol.28 (3), p.534-549

2018

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Clinically relevant QTc prolongation is not associated with current dose schedules of LBH589 (panobinostat)

Journal of clinical oncology, 2008-01, Vol.26 (2), p.332-333

2008

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Challenges and Opportunities in Rare Disease Drug Development

Drug Development for Rare Diseases, 2023, p.7-15

1, 2023

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Introduction to Rare Disease Therapy Development

Drug Development for Rare Diseases, 2023, p.1-6

1, 2023

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Clinical Trial Design and Analysis Considerations for Rare Diseases

Drug Development for Rare Diseases, 2023, p.35-100

1, 2023

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A Bayesian Case Study in Oncology Phase I Combination Dose-Finding Using Logistic Regression with Covariates

Journal of biopharmaceutical statistics, 2009-05, Vol.19 (3), p.469-484

2009

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A randomized, double-blinded, phase II study of paclitaxel/carboplatin (PC) plus CT-322 versus PC plus bevacizumab (Bev) as first-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC)

Journal of clinical oncology, 2012-05, Vol.30 (15_suppl), p.7584-7584

2012

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Psychiatric Comorbidity and Not Completing Jail-based Substance Abuse Treatment

The American journal on addictions, 2004-01, Vol.13 (1), p.83-101

2004

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Phase II Trial of Oral Panobinostat (LBH589) in Patients with Refractory Cutaneous T-Cell Lymphoma (CTCL)

Blood, 2008-11, Vol.112 (11), p.1005-1005

2008

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Phase IA/II Study of Oral Panobinostat (LBH589), a Novel Pan- Deacetylase Inhibitor (DACi) Demonstrating Efficacy in Patients with Advanced Hematologic Malignancies

Blood, 2008-11, Vol.112 (11), p.958-958

2008

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Phase IA/II Study of Oral LBH589, a Novel Deacetylase Inhibitor (DACi), Administered on 2 Schedules, in Patients with Advanced Hematologic Malignancies

Blood, 2007-11, Vol.110 (11), p.907-907

2007

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Jail-Based Substance User Treatment: An Analysis of Retention

Substance use & misuse, 2003-01, Vol.38 (9), p.1227-1258

2003

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A Phase I/II Study of Intravenous LBH589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Patients (pts) with Advanced Hematologic Malignancies

Blood, 2004-11, Vol.104 (11), p.1802-1802

2004

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Nonparametric inference for the proportionality function in the random censorship model

Journal of nonparametric statistics, 2003-04, Vol.15 (2), p.151-169

2003

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Maximum likelihood estimation in the proportional hazards model of random censorship

Statistics (Berlin, DDR), 2001-01, Vol.35 (3), p.245-258

2001

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Nonparametric inference for the proportionality function in the random censorship model

Laird, Glen Howard

2000

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Beyond exposure‐response: A tutorial on statistical considerations in dose‐ranging studies

A Phase I Study of Intravenous LBH589, a Novel Cinnamic Hydroxamic Acid Analogue Histone Deacetylase Inhibitor, in Patients with Refractory Hematologic Malignancies

A Bayesian phase II proof‐of‐concept design for clinical trials with longitudinal endpoints

Goodness-of-fit test for proportional subdistribution hazards model

Adaptive hybrid control design for comparative clinical trials with historical control data

Design and analysis of drop-the-losers studies using binary endpoints in the rare disease setting

A confirmatory basket design considering non-inferiority and superiority testing

Burden of cystic fibrosis in children <12 years of age prior to the introduction of CFTR modulator therapies

Burden of cystic fibrosis in children

Bayesian additive decision trees of biomarker by treatment interactions for predictive biomarker detection and subgroup identification

Clinically relevant QTc prolongation is not associated with current dose schedules of LBH589 (panobinostat)

Challenges and Opportunities in Rare Disease Drug Development

Introduction to Rare Disease Therapy Development

Clinical Trial Design and Analysis Considerations for Rare Diseases

A Bayesian Case Study in Oncology Phase I Combination Dose-Finding Using Logistic Regression with Covariates

A randomized, double-blinded, phase II study of paclitaxel/carboplatin (PC) plus CT-322 versus PC plus bevacizumab (Bev) as first-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC)

Psychiatric Comorbidity and Not Completing Jail-based Substance Abuse Treatment

Phase II Trial of Oral Panobinostat (LBH589) in Patients with Refractory Cutaneous T-Cell Lymphoma (CTCL)

Phase IA/II Study of Oral Panobinostat (LBH589), a Novel Pan- Deacetylase Inhibitor (DACi) Demonstrating Efficacy in Patients with Advanced Hematologic Malignancies

Phase IA/II Study of Oral LBH589, a Novel Deacetylase Inhibitor (DACi), Administered on 2 Schedules, in Patients with Advanced Hematologic Malignancies

Jail-Based Substance User Treatment: An Analysis of Retention

A Phase I/II Study of Intravenous LBH589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Patients (pts) with Advanced Hematologic Malignancies

Nonparametric inference for the proportionality function in the random censorship model

Maximum likelihood estimation in the proportional hazards model of random censorship

Nonparametric inference for the proportionality function in the random censorship model

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