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By Patrick Waller - An Introduction to Pharmacovigilance
1405194715|9781405194716. An Introduction to Pharmacovigilance published in the year 2009 was published by Wiley-Blackwell. View 14630 more books by Blackwell Publishing. The author of this book is Patrick Waller. page displaying collection of Patrick Waller books here. This is the Paperback version of the title "An Introduction to Pharmacovigilance " and have around pp. 120 pages. An Introduction to Pharmacovigilance is currently Available with us.
Paperback
First published September 22, 2009
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August 5, 2017
A good review of fundamental concepts in public health--particularly epidemiology--as they apply to pharmacovigilance.
The best parts of the book were the chapters on basic concepts, types and sources of data, the process of PV, and clinical aspects of PV. Found it especially interesting and useful to read about statistical methods applied to various strategies, ranging from meta analyses and prescription event monitoring, to signal detection using disproportionality approaches.
Did a good job of communicating clearly that signal detection is a screening function, requiring confirmation via subsequent drill down due diligence. Also enjoyed the discussions on communications and risk management planning.
The book would have benefited from having a glossary of acronyms, particularly for the chapter on regulatory aspects of pharmacovigilance. Too often, I found myself trying to track down what the acronym stood for, without recalling the page it's defined on.
Chapter on ethics and future direction were ok. The former was a bit trite and the latter offered little value added. Missed opportunities to truly highlight the cath-22 of the Helsinki declaration steering research away from vulnerable populations for safety reasons (i.e., pediatrics, pregnant patients) on the one hand, and on the other hand, the fact that the medical community is increasingly protesting the information disadvantage that we face wrt adverse drug events because clinical trials exclude these populations.
The best parts of the book were the chapters on basic concepts, types and sources of data, the process of PV, and clinical aspects of PV. Found it especially interesting and useful to read about statistical methods applied to various strategies, ranging from meta analyses and prescription event monitoring, to signal detection using disproportionality approaches.
Did a good job of communicating clearly that signal detection is a screening function, requiring confirmation via subsequent drill down due diligence. Also enjoyed the discussions on communications and risk management planning.
The book would have benefited from having a glossary of acronyms, particularly for the chapter on regulatory aspects of pharmacovigilance. Too often, I found myself trying to track down what the acronym stood for, without recalling the page it's defined on.
Chapter on ethics and future direction were ok. The former was a bit trite and the latter offered little value added. Missed opportunities to truly highlight the cath-22 of the Helsinki declaration steering research away from vulnerable populations for safety reasons (i.e., pediatrics, pregnant patients) on the one hand, and on the other hand, the fact that the medical community is increasingly protesting the information disadvantage that we face wrt adverse drug events because clinical trials exclude these populations.
Displaying 1 of 1 review