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Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial

The Lancet (British edition), 2021-06, Vol.397 (10290), p.2169-2181

2021

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How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions

Therapeutic innovation & regulatory science, 2024-07, Vol.58 (4), p.579-590

2024

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Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-03, Vol.21 (2), p.372-385

2022

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Clinical Aspects and Pathophysiology of Inflammatory Bowel Disease

Clinical Microbiology Reviews, 2002-01, Vol.15 (1), p.79-c

2002

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Value and Implementation of the Aggregate Safety Assessment Plan

Pharmaceutical medicine, 2023-05, Vol.37 (3), p.171-181

2023

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Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis

American journal of clinical dermatology, 2018-06, Vol.19 (3), p.437-447

2018

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Designing for Play

Hedricks, Barbara E

Second edition., 2018

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Monitoring Drug Safety in Rheumatoid Arthritis Prevention Trials

Clinical therapeutics, 2019-07, Vol.41 (7), p.1366-1375

2019

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RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 α1 and α2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study

Advances in therapy, 2017-06, Vol.34 (6), p.1364-1381

2017

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Interdisciplinary Safety Evaluation for Learning and Decision-Making

Therapeutic innovation & regulatory science, 2021-07, Vol.55 (4), p.705-716

2021

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Heterologous Protection Induced by the Inner Capsid Proteins of Rotavirus Requires Transcytosis of Mucosal Immunoglobulins

Journal of Virology, 2002-08, Vol.76 (16), p.8110-8117

2002

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Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

Therapeutic innovation & regulatory science, 2021-07, Vol.55 (4), p.717-732

2021

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A Framework for Safety Evaluation Throughout the Product Development Life-Cycle

Therapeutic innovation & regulatory science, 2020-07, Vol.54 (4), p.821-830

2020

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Fibrosing Mediastinitis Caused by Histoplasmosis in an Adolescent

JACC. Case reports, 2024-01, Vol.29 (2), p.102161, Article 102161

2024

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Polymeric Immunoglobulin Receptor in Intestinal Immune Defense against the Lumen-Dwelling Protozoan Parasite Giardia

Journal of Immunology, 2006-11, Vol.177 (9), p.6281-6290

2006

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Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Therapeutic innovation & regulatory science, 2020-03, Vol.54 (2), p.447-461

2020

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Enteric flora and lymphocyte-derived cytokines determine expression of heat shock proteins in mouse colonic epithelial cells

Gastroenterology (New York, N.Y. 1943), 2003-05, Vol.124 (5), p.1395-1407

2003

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Pneumonia With Chest Wall Invasion in a School-Aged Child

Journal of the Pediatric Infectious Diseases Society, 2014-12, Vol.3 (4), p.e42-e44

2014

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Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme

Annals of the rheumatic diseases, 2021-03, Vol.80 (3), p.304

2021

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Assessing adverse events in clinical trials during the era of the COVID-19 pandemic

Journal of biopharmaceutical statistics, 2023-07, Vol.33 (4), p.466-475

2023

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Protective role of HSP72 against Clostridium difficile toxin A-induced intestinal epithelial cell dysfunction

American Journal of Physiology: Cell Physiology, 2003-04, Vol.284 (4), p.C1073-C1082

2003

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Protection against rotavirus shedding after intranasal immunization of mice with a chimeric VP6 protein does not require intestinal IgA

Virology (New York, N.Y.), 2006-03, Vol.346 (2), p.338-347

2006

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Gastric Inflammation as a Feature of Ulcerative Colitis

Journal of pediatric gastroenterology and nutrition, 2003-09, Vol.37 (3), p.228-229

Hendrickson, Barbara A

2003

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Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies

Journal of allergy and clinical immunology, 2023-01, Vol.151 (1), p.172-181

2023

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Aggregate IND Safety Reporting for Smaller Companies and Programs

Therapeutic innovation & regulatory science, 2024-03, Vol.58 (2), p.368-379

2024

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Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial

How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions

Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation

Clinical Aspects and Pathophysiology of Inflammatory Bowel Disease

Value and Implementation of the Aggregate Safety Assessment Plan

Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis

Designing for Play

Monitoring Drug Safety in Rheumatoid Arthritis Prevention Trials

RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 α1 and α2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study

Interdisciplinary Safety Evaluation for Learning and Decision-Making

Heterologous Protection Induced by the Inner Capsid Proteins of Rotavirus Requires Transcytosis of Mucosal Immunoglobulins

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

A Framework for Safety Evaluation Throughout the Product Development Life-Cycle

Fibrosing Mediastinitis Caused by Histoplasmosis in an Adolescent

Polymeric Immunoglobulin Receptor in Intestinal Immune Defense against the Lumen-Dwelling Protozoan Parasite Giardia

Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Enteric flora and lymphocyte-derived cytokines determine expression of heat shock proteins in mouse colonic epithelial cells

Pneumonia With Chest Wall Invasion in a School-Aged Child

Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme

Assessing adverse events in clinical trials during the era of the COVID-19 pandemic

Protective role of HSP72 against Clostridium difficile toxin A-induced intestinal epithelial cell dysfunction

Protection against rotavirus shedding after intranasal immunization of mice with a chimeric VP6 protein does not require intestinal IgA

Gastric Inflammation as a Feature of Ulcerative Colitis

Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies

Aggregate IND Safety Reporting for Smaller Companies and Programs

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