Recent Advancements in the Analysis and Presentation of Safety Data
- 1 April 2001
- journal article
- other
- Published by Springer Science and Business Media LLC in Drug Information Journal
- Vol. 35 (2), 377-397
- https://doi.org/10.1177/009286150103500207
Abstract
The importance of a favorable safety profile to the overall success of a pharmaceutical product is well known. While most of the analysis of safety data is routine and exploratory in nature, we will discuss some options to examine safety data in greater detail. Some of these options represent recent advancements in the statistical and graphical procedures to present and analyze safety data.Keywords
This publication has 5 references indexed in Scilit:
- Bayesian Data Mining in Large Frequency Tables, with an Application to the FDA Spontaneous Reporting SystemThe American Statistician, 1999
- An application of meta-analysis techniques in the evaluation of adverse experiences with antihypertensive agentsPharmacoepidemiology and Drug Safety, 1999
- Incidence of Adverse Drug Reactions in Hospitalized PatientsJAMA, 1998
- Does Research Synthesis Have a Place in Drug Regulatory Policy? Synopsis of Issues: Assessment of Safety and Postmarketing SurveillanceClinical Research and Regulatory Affairs, 1996
- EEC Pharmacovigilance and the Pharmaceutical Industry: Common Market, Common Rules?Drug Information Journal, 1992