Real-world data: Assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products
Pharmacoepidemiol Drug Saf
.
2022 Jul;31(7):717-720.
doi: 10.1002/pds.5444.
Epub 2022 May 3.
Authors
Cynthia J Girman
1
,
Mary E Ritchey
1
2
3
,
Vincent Lo Re 3rd
4
Affiliations
1
Real World Evidence and Patient Outcomes, CERobs Consulting, LLC, Wrightsville Beach, North Carolina, USA.
2
Med Tech Epi, LLC, Philadelphia, Pennsylvania, USA.
3
Center for Pharmacoepidemiology & Treatment Science, Rutgers University, New Brunswick, New Jersey, USA.
4
Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
PMID:
35471704
PMCID:
PMC9320939
DOI:
10.1002/pds.5444
No abstract available
MeSH terms
Biological Products* / adverse effects
Databases, Factual
Decision Making
Electronic Health Records*
Humans
Substances
Biological Products