Detalhe da pesquisa
1.
Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies.
J Allergy Clin Immunol
; 151(1): 172-181, 2023 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-36195170
2.
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic.
J Biopharm Stat
; 33(4): 466-475, 2023 Jul 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-36717961
3.
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.
Lancet
; 397(10290): 2169-2181, 2021 06 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-34023009
4.
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.
Pharm Stat
; 21(2): 372-385, 2022 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-34725911
5.
Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme.
Ann Rheum Dis
; 80(3): 304-311, 2021 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-33115760
6.
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions.
Ther Innov Regul Sci
; 58(4): 579-590, 2024 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-38555342
7.
Aggregate IND Safety Reporting for Smaller Companies and Programs.
Ther Innov Regul Sci
; 58(2): 368-379, 2024 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-38190028
8.
Fibrosing Mediastinitis Caused by Histoplasmosis in an Adolescent.
JACC Case Rep
; 29(2): 102161, 2024 Jan 17.
Artigo
em Inglês
| MEDLINE | ID: mdl-38264300
9.
Value and Implementation of the Aggregate Safety Assessment Plan.
Pharmaceut Med
; 37(3): 171-181, 2023 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-37072647
10.
Local vaccine site reactions and contact allergy to aluminum.
Pediatr Dermatol
; 29(1): 68-72, 2012.
Artigo
em Inglês
| MEDLINE | ID: mdl-21854416
11.
Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study.
RMD Open
; 8(1)2022 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-35246470
12.
Interdisciplinary Safety Evaluation for Learning and Decision-Making.
Ther Innov Regul Sci
; 55(4): 705-716, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33730364
13.
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle.
Ther Innov Regul Sci
; 55(4): 717-732, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33755928
14.
A Framework for Safety Evaluation Throughout the Product Development Life-Cycle.
Ther Innov Regul Sci
; 54(4): 821-830, 2020 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-32557298
15.
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.
Ther Innov Regul Sci
; 54(2): 447-461, 2020 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-32072595
16.
Monitoring Drug Safety in Rheumatoid Arthritis Prevention Trials.
Clin Ther
; 41(7): 1366-1375, 2019 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-31078317
17.
Incidence of inpatient venous thromboembolism in treated patients with rheumatoid arthritis and the association with switching biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in the real-world setting.
RMD Open
; 5(2): e001013, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31673413
18.
Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.
Am J Clin Dermatol
; 19(3): 437-447, 2018 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-29380251
19.
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.
Adv Ther
; 34(6): 1364-1381, 2017 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-28455782
20.
Pneumonia With Chest Wall Invasion in a School-Aged Child.
J Pediatric Infect Dis Soc
; 3(4): e42-4, 2014 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26625462