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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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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
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  Data: 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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  Data: <searchLink fieldCode="AU" term="%22Bissonnette+R%22">Bissonnette R</searchLink>; Innovaderm Research, Inc., 3530 St-Laurent Blvd, Suite 300, Montreal, QC, H2X 2V1, Canada. rbissonnette@innovaderm.ca.<br /><searchLink fieldCode="AU" term="%22Gottlieb+AB%22">Gottlieb AB</searchLink>; Icahn School of Medicine at Mount Sinai, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Langley+RG%22">Langley RG</searchLink>; Dalhousie University, Halifax, NS, Canada.<br /><searchLink fieldCode="AU" term="%22Leonardi+CL%22">Leonardi CL</searchLink>; Saint Louis University Medical School, St Louis, MO, USA.<br /><searchLink fieldCode="AU" term="%22Papp+KA%22">Papp KA</searchLink>; K. Papp Clinical Research and Probity Research Inc., Waterloo, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Pariser+DM%22">Pariser DM</searchLink>; Eastern Virginia Medical School, Norfolk, VA, USA.<br /><searchLink fieldCode="AU" term="%22Uy+J%22">Uy J</searchLink>; Janssen Scientific Affairs, LLC, Horsham, PA, USA.<br /><searchLink fieldCode="AU" term="%22Lafferty+KP%22">Lafferty KP</searchLink>; Janssen Scientific Affairs, LLC, Horsham, PA, USA.<br /><searchLink fieldCode="AU" term="%22Langholff+W%22">Langholff W</searchLink>; Janssen Research & Development, LLC, Spring House, PA, USA.<br /><searchLink fieldCode="AU" term="%22Fakharzadeh+S%22">Fakharzadeh S</searchLink>; Janssen Global Services, LLC, Horsham, PA, USA.<br /><searchLink fieldCode="AU" term="%22Berlin+JA%22">Berlin JA</searchLink>; Johnson & Johnson Epidemiology, Titusville, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Brouwer+ES%22">Brouwer ES</searchLink>; Janssen Research & Development, LLC, Spring House, PA, USA.<br /><searchLink fieldCode="AU" term="%22Greenspan+AJ%22">Greenspan AJ</searchLink>; Janssen Scientific Affairs, LLC, Horsham, PA, USA.<br /><searchLink fieldCode="AU" term="%22Strober+BE%22">Strober BE</searchLink>; Yale University, New Haven, CT, USA.; Central Connecticut Dermatology Research, Cromwell, CT, USA.
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  Data: <searchLink fieldCode="JN" term="%229002928%22">Drug safety</searchLink> [Drug Saf] 2021 Jun; Vol. 44 (6), pp. 699-709. <i>Date of Electronic Publication: </i>2021 Jun 02.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>9002928 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1942 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201145916%22">01145916 </searchLink><i>NLM ISO Abbreviation: </i>Drug Saf <i>Subsets: </i>MEDLINE
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              Text: 2021 Jun
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