Last Updated: 09/26/2026
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Found 20 publications
Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.
Journal: Pharmaceutical medicine
Published: November 26, 2025
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions.
Journal: Therapeutic innovation & regulatory science
Published: October 24, 2023
Fibrosing Mediastinitis Caused by Histoplasmosis in an Adolescent.
Journal: JACC. Case reports
Published: September 27, 2023
Aggregate IND Safety Reporting for Smaller Companies and Programs.
Journal: Therapeutic innovation & regulatory science
Published: July 29, 2023
Value and Implementation of the Aggregate Safety Assessment Plan.
Journal: Pharmaceutical medicine
Published: March 09, 2023
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic.
Journal: Journal of biopharmaceutical statistics
Published: January 31, 2023
Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies.
Journal: The Journal of allergy and clinical immunology
Published: April 28, 2022
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.
Journal: Lancet (London, England)
Published: December 11, 2020
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.
Journal: Pharmaceutical statistics
Published: December 08, 2020
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle.
Journal: Therapeutic innovation & regulatory science
Published: December 06, 2020
Interdisciplinary Safety Evaluation for Learning and Decision-Making.
Journal: Therapeutic innovation & regulatory science
Published: October 07, 2020
Last Updated: 09/26/2026