Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR.

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Bibliographic Details
Title: Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR.
Authors: Bissonnette R; Innovaderm Research, Inc., 3530 St-Laurent Blvd, Suite 300, Montreal, QC, H2X 2V1, Canada. rbissonnette@innovaderm.ca., Gottlieb AB; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Langley RG; Dalhousie University, Halifax, NS, Canada., Leonardi CL; Saint Louis University Medical School, St Louis, MO, USA., Papp KA; K. Papp Clinical Research and Probity Research Inc., Waterloo, ON, Canada., Pariser DM; Eastern Virginia Medical School, Norfolk, VA, USA., Uy J; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Lafferty KP; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Langholff W; Janssen Research & Development, LLC, Spring House, PA, USA., Fakharzadeh S; Janssen Global Services, LLC, Horsham, PA, USA., Berlin JA; Johnson & Johnson Epidemiology, Titusville, NJ, USA., Brouwer ES; Janssen Research & Development, LLC, Spring House, PA, USA., Greenspan AJ; Janssen Scientific Affairs, LLC, Horsham, PA, USA., Strober BE; Yale University, New Haven, CT, USA.; Central Connecticut Dermatology Research, Cromwell, CT, USA.
Source: Drug safety [Drug Saf] 2021 Jun; Vol. 44 (6), pp. 699-709. Date of Electronic Publication: 2021 Jun 02.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't; Review
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1179-1942
DOI:10.1007/s40264-021-01065-z