March 27, 2023
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters (Therapeutic Innovation & Regulatory Science)
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Journal Articles
March 7, 2023
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources (Journal of Biopharmaceutical Statistics)
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January 20, 2023
Pharmacovigilance Agreement Optimization (PVAO): Tools to Create a Customized PVA (Therapeutic Advances in Drug Safety)
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January 18, 2023
Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions (Pharmaceutical Medicine)
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December 24, 2022
Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks (Drug Safety)
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May 17, 2022
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance (Drug Safety)
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May 17, 2022
Black Swan Events and Intelligent Automation for Routine Safety Surveillance (Drug Safety)
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September 2, 2021
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations (Digital Biomarkers)
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August 13, 2021
SEND Harmonization & cross-study analysis: A Proposal to Better Harvest the Value from SEND Data (PHUSE)
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August 13, 2021
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials (TIRS)
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