A flexible mixed‐data model applied to claims data for post‐market surveillance of prescription drug safety behavior-Reference-Cited by-同舟云学术

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A flexible mixed‐data model applied to claims data for post‐market surveillance of prescription drug safety behavior

Published:2022-04-03 Issue:5 Volume:21 Page:1022-1036
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Butler Harris¹^ORCID,Rice John D.¹,Carlson Nichole E.¹,Morrato Elaine H.²³

Affiliation:

1. Biostatistics and Informatics, Colorado School of Public Health University of Colorado Anschutz Medical Campus Aurora Colorado USA

2. Parkinson School of Health Sciences and Public Health Loyola University Chicago Chicago Illinois USA

3. Health Systems, Management, and Policy, Colorado School of Public Health University of Colorado Anschutz Medical Campus Aurora Colorado USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2213

Reference33 articles.

1. US Food and Drug Administration.Approved Risk Evaluation and Mitigation Strategies (REMS). 2019. Accessed March 1 2020.https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

2. Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function

3. U.S. Food and Drug Administration.REMS Assessment: Planning and Reporting Draft Guidance for Industry. Procedural. January 2019.https://www.fda.gov/media/119790/

4. National Council of State Legislatures.Collecting Health Data: All‐Payer Claims Databases. May 2010.https://www.ncsl.org/portals/1/documents/health/ALL-PAYER_CLAIMS_DB-2010.pdf

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