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S943 Analysis of International Spontaneous Reporting System Databases for Safety of Corticosteroids in Inflammatory Bowel Disease: The Determinants, Incidence and Consequences of Corticosteroid Excess (DICE)-Impact Study

The American journal of gastroenterology, 2021-10, Vol.116 (1), p.S448-S449

2021

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Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

Drug safety, 2018-06, Vol.41 (6), p.625-640

2018

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Quantitative Drug Safety and Benefit-Risk Evaluation: Practical and Cross-Disciplinary Approaches

1, 2022

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Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

Drug safety, 2018-12, Vol.41 (12), p.1431-1437

2018

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Coadministration of Pioglitazone or Glyburide and Alogliptin: Pharmacokinetic Drug Interaction Assessment in Healthy Participants

Journal of clinical pharmacology, 2009-10, Vol.49 (10), p.1210-1219

2009

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Quantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation

2021

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Differences in the Adverse Event Burden of Corticosteroid Use in Inflammatory Bowel Disease as Reported Between Adverse Event Reporting Systems and a Patient Questionnaire

Journal of Crohn's and colitis, 2024-09

2024

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Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Statistics in biopharmaceutical research, 2020-10, Vol.12 (4), p.498-505

2020

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Effects of Food Intake on the Pharmacokinetics of Azilsartan Medoxomil and Chlorthalidone Alone and in Fixed-Dose Combination in Healthy Adults

Clinical pharmacology in drug development, 2016-09, Vol.5 (5), p.393-398

2016

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Predictors of Non-response or Loss of Response to Tumour Necrosis Factor Antagonist Therapies in Inflammatory Bowel Disease: 699

The American journal of gastroenterology, 2016-10, Vol.111, p.S316

2016

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On Quantitative Methods for Clinical Safety Monitoring in Drug Development

Statistics in biopharmaceutical research, 2018-04, Vol.10 (2), p.85-97

2018

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Criteria to Assess In Vivo Performance and Bioequivalence of Generic Controlled‐Release Formulations of Carbamazepine

Epilepsia (Copenhagen), 1998-05, Vol.39 (5), p.513-519

1998

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Effect of Vortioxetine on Cardiac Repolarization in Healthy Adult Male Subjects: Results of a Thorough QT/QTc Study

Clinical pharmacology in drug development, 2013-10, Vol.2 (4), p.298-309

2013

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Quantitative Methods for Blinded Safety Monitoring

Quantitative Drug Safety and Benefit-Risk Evaluation, 2022, Vol.1, p.119-132

1, 2022

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Randomized, Placebo-Controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression

Biological psychiatry (1969), 2003-10, Vol.54 (8), p.806-817

2003

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The effects of psychotherapy, nefazodone, and their combination on subjective assessment of disturbed sleep in chronic depression

Sleep (New York, N.Y.), 2003-03, Vol.26 (2), p.130-136

2003

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Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches

1, 2002

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Software for Bayesian Computation-An Overview of Some Currently Available Tools

Bayesian Applications in Pharmaceutical Development, 2020, p.375-407

1, 2020

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Reporting of Bayesian Analyses in Clinical Research: Some Recommendations

Bayesian Applications in Pharmaceutical Development, 2020, p.187-224

1, 2020

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A Question-Based Approach to the Analysis of Safety Data

Biopharmaceutical Applied Statistics Symposium, 2018, p.193-216

2018

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Meta-Analysis of Drug Safety Assessment

Quantitative Drug Safety and Benefit-Risk Evaluation, 2022, Vol.1, p.187-212

1, 2022

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Leveraging Machine Learning, Natural Language Processing, and Deep Learning in Drug Safety and Pharmacovigilance

Data Science, AI, and Machine Learning in Drug Development, 2023, p.193-229

1, 2023

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Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices

Quantitative Drug Safety and Benefit-Risk Evaluation, 2022, Vol.1, p.285-315

1, 2022

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Safety Signaling and Causal Evaluation

Quantitative Drug Safety and Benefit-Risk Evaluation, 2022, Vol.1, p.45-76

1, 2022

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Visual Analytics of Safety and Benefit-Risk from Clinical Trial Data

Quantitative Drug Safety and Benefit-Risk Evaluation, 2022, Vol.1, p.351-373

1, 2022

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S943 Analysis of International Spontaneous Reporting System Databases for Safety of Corticosteroids in Inflammatory Bowel Disease: The Determinants, Incidence and Consequences of Corticosteroid Excess (DICE)-Impact Study

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

Quantitative Drug Safety and Benefit-Risk Evaluation: Practical and Cross-Disciplinary Approaches

Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

Coadministration of Pioglitazone or Glyburide and Alogliptin: Pharmacokinetic Drug Interaction Assessment in Healthy Participants

Quantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation

Differences in the Adverse Event Burden of Corticosteroid Use in Inflammatory Bowel Disease as Reported Between Adverse Event Reporting Systems and a Patient Questionnaire

Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Effects of Food Intake on the Pharmacokinetics of Azilsartan Medoxomil and Chlorthalidone Alone and in Fixed-Dose Combination in Healthy Adults

Predictors of Non-response or Loss of Response to Tumour Necrosis Factor Antagonist Therapies in Inflammatory Bowel Disease: 699

On Quantitative Methods for Clinical Safety Monitoring in Drug Development

Criteria to Assess In Vivo Performance and Bioequivalence of Generic Controlled‐Release Formulations of Carbamazepine

Effect of Vortioxetine on Cardiac Repolarization in Healthy Adult Male Subjects: Results of a Thorough QT/QTc Study

Quantitative Methods for Blinded Safety Monitoring

Randomized, Placebo-Controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression

The effects of psychotherapy, nefazodone, and their combination on subjective assessment of disturbed sleep in chronic depression

Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches

Software for Bayesian Computation-An Overview of Some Currently Available Tools

Reporting of Bayesian Analyses in Clinical Research: Some Recommendations

A Question-Based Approach to the Analysis of Safety Data

Meta-Analysis of Drug Safety Assessment

Leveraging Machine Learning, Natural Language Processing, and Deep Learning in Drug Safety and Pharmacovigilance

Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices

Safety Signaling and Causal Evaluation

Visual Analytics of Safety and Benefit-Risk from Clinical Trial Data

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