Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

Therapeutic Innovation & Regulatory Science
Kalaiselvan VivekanandanGyanendra Nath Singh

Abstract

The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI. Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures. The effectiveness of the proposed methods was assessed by applying them to 4 drug-ADR combinations. The proposed methods were easy to apply and relevant to the Indian context. In selected methods, the information component value was more specific, whereas the proportional relative risk was more sensitive. The proposed methods may help in the identification of new signals in Indian individual case safety reports.

References

Aug 11, 1998·European Journal of Clinical Pharmacology·A BateR M De Freitas
Jun 20, 2002·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Andrew BateRoland Orre
Jan 1, 2012·Pharmaceutics·Marc Suling, Iris Pigeot
Jul 24, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ola CasterG Niklas Norén
Aug 3, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Vivekanandan KalaiselvanGyanendra Nath Singh
May 1, 2014·Therapeutic Innovation & Regulatory Science·Kalaiselvan VivekanandanGyanendra Nath Singh

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Citations

Sep 20, 2016·Indian Journal of Pediatrics·Vivekanandan KalaiselvanGyanendra Nath Singh
Jan 1, 2017·Therapeutic Innovation & Regulatory Science·Aman KumarVivekanandan Kalaiselvan
Jul 19, 2021·Seizure : the Journal of the British Epilepsy Association·Shatrunajay ShuklaBikash Medhi

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Software Mentioned

PvPI Analysis System
VigiMine
Excel

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