Ronald D. Mann, Elizabeth B. Andrews
John Wiley & Sons, Jan 24, 2003 - Medical - 582 pages
Interest in the field of pharmacovigilance has grown rapidly in recent years with the possible toxicity of a drug becoming as much a focus of clinical trials as its benefits. This key text is a definitive resource for professionals working within pharmacovigilance. Written by leading professionals in the field, its clear structure, covers all the important aspects of the subject including:-
* Legal aspects
* Drug regulatory requirements
* Methods of signal generation
* Reporting schemes
* Pharmacovigilance in selected system-organ classes
* Future directions
This comprehensive book should be in all pharmacovigilance departments, regional
pharmacovigilance centres and regulatory authorities. It is an unparalleled
source of information and reference for all researchers in pharmacovigilance, pharmaceutical practice and medicine.
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
2002 John Wiley ADR reporting ADRs adverse drug reactions adverse events adverse reactions Agency and=or associated Bayesian Begaud CIOMS Clin Pharmacol clinical trials cohort database disease dose Drug Administration drug safety drug-induced effects elderly enzyme epidemiology evaluation exposure genetic GPRD haemolytic anaemia haemopoietic reactions hepatitis hepatotoxicity hospital identified imputation incidence increased individual inhibitors interactions International issues lamotrigine liver Mann and EB marketing authorisation medicinal products metabolism metabolite methods monitoring national centre nomifensine NSAIDs number of reports outcome patients pharmacists Pharmacoepidemiology Pharmacoepidemiology and Drug pharmacovigilance population postmarket potential pregnancy prenylamine prescribing prescription product–AE public health QT interval reactions reported registries regulatory serious signal specific spontaneous reporting statistical surveillance syndrome Table terodiline therapy tion torsades de pointes toxicity treatment United Kingdom Uppsala Monitoring Centre vaccine warfarin Yellow Card Yellow Card Scheme