Chapter-16 Computer-Based System Approach
BOOK TITLE: Textbook of Pharmacovigilance
Author
1. Akhtar Kamal
ISBN
9789350252062
DOI
10.5005/jp/books/11442_16
Edition
1/e
Publishing Year
2011
Pages
23
Author Affiliations
1.
Institute of Clinical Research (India), A-201, Okhla Phase-1, Industrial Area, New Delhi, India
Chapter keywords
SE Massengill Company,
thalidomide tragedy,
Vioxx,
pharmacovigilance,
paper-based method,
computer-based methods,
indexing and hyperlinking,
importation,
data standards and interoperable systems,
high quality safety data,
re-structuring capabilities,
data analysis,
reproducibility,
Coronary Thrombosis,
MedDRA,
Heterogeneous Patients,
Adverse Event Relationship,
concomitant medications,
Submission Data Tabulation Model,
Multi-Item Gamma Poisson Shrinker,
Hierarchical Bayesian Logistic Regression,
Galt Safety Suite,
Insightful Safety™,
Empirica Suite™,
ArisGlobal,
Galt Associates Inc.,
Insightful,
Oracle,
Phase Forward,
Relsys Inc.,
eResearch Technology (eRT),
SAIC,
SAS