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clinical significance

19 papers and 5 presentations; 24 titles.

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Conference × Year × Title × Authors Extras Pages
PHUSE US 2026 Enhancing Clinical Study Report Authoring with Generative AI: Lessons Learned on TFL Formatting and Metadata Integration in Merck's iRAP Tool Elisabeth Pyle,
Madhusudhan Reddy Papasani
source
presentation source
4
PHUSE APAC 2026 AI for Adverse Event Signal Detection: Moving Beyond Monika Monika source
presentation source
10
PHUSE APAC 2026 Crafting a recipe for success : Aligning Target Product Profiles and study design to ensure statistical significance translates to clinical relevance and role of DGF Soumitra Kar,
Novo Nordisk GBS
source
presentation source
9
PHUSE APAC 2026 Elastic Net Meets BART: A Hybrid Virtual Twins Approach for Reliable Subgroup Identification Alexis Bernard Dalam source
presentation source
10
PHUSE APAC 2026 Resistance Data Revolution: Insights, Challenges and FDA Compliance Implementation Sujith Mididoddi source
poster source
3
PHUSE US 2025 More Than a p-Value: Understanding the Differences Between Clinical and Statistical Significance Jasperlynn Kao,
Elnaz Ghadimi
source
presentation source
4
WUSS 2024 Correlation of a Composite Self-Reported Symptoms Severity Score with Patient Number of Symptoms as Predictors of SARS-CoV-2 infection status/Viral Load using the SAS System [presentation] Jesse Albert Canchola,
Daniel Jarem,
Alison Kuchta
source 54
PharmaSUG 2022 Win Ratio Simulation For Power Calculation Made Easy Lili Li,
Roger Chang,
Benjamin Fine,
Yu-Chen Su
source 13
PHUSE US 2021 Interactive Visualization and Summarization of Toxicology Study Results Across Species, Routes and Durations Throughout a Drug Development Program Using R Shiny [presentation] Kevin Snyder,
Md Yousuf Ali
source
video
14
PHUSE US 2021 Neurological Examination and Procedure Results in SDTM: Challenges and Solutions [presentation] Shivam Kumar source
video
14
PharmaSUG 2021 Shiny decisions - An R-shiny application for decision frameworks Lasse Nielsen source 6
PHUSE EU 2020 Enabling Novel Digital Endpoints in Clinical Trials for Regulatory Purposes: Bringing Efficiency to the Industry by Creating a Service-based Ecosystem [presentation] Bert Hartog,
Kai Langel
source
video
14
PHUSE EU 2020 SUPPQUAL Datasets: The Good, the Bad and the Ugly [presentation] Sergiy Sirichenko source
video
40
PHUSE EU 2013 ADaM Datasets - Standard and Submission Ready Karin Fleischer Steffensen source
presentation source
6
PHUSE EU 2012 Misinterpretation of Statistics - An Introduction John Salter source
presentation source
9
PharmaSUG 2012 Common Misunderstandings about ADaM Implementation Nate Freimark,
Susan J. Kenny,
Jack Shostak,
John K. Troxell
source 10
PharmaSUG 2011 Ensuring Consistent Data Mapping Across SDTM-based Studies - a Data Warehouse Approach Annie S. Guo source 12
MWSUG 2010 A DOE "Real Life" Example: Solid Phase Optimization of a Diagnostic Immunoassay Steve Figard 11
NESUG 2009 A Practical Introduction to implementing the Clinical Data Acquisition Standards Harmonization (CDASH) standards Jennifer Price 7
PharmaSUG 2009 A Practical Introduction to Clinical Data Acquisition Standards Harmonization (CDASH) Jennifer Price 5
SUGI 2000 Design and Analysis of Cancer Control Studies via the SAS System Jeff A. Sloan,
Charles L. Loprinzi,
Paul J. Novotny
source 10
SUGI 1998 Skaff and Jeff A. Sloan Design and Analysis of Equivalence Clinical T rials V ia the SAS System Pamela J. Atherton source 7
WUSS 1995 Method Comparison Using Bland-Altman Method Meng-Koon Chua source 5
SUGI 1995 Controlling Your Programs with Data: An Example in Pharmaceutical Laboratory Data Reporting Paul C. Wehr,
Albert Mo
source 6

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