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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

Abstract

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