Drug Safety Data: How to Analyze, Summarize, and Interpret to Determine Risk

I've met one of the authors and attended one of his lectures on PV. After reviewing several of the chapters for medical writing, I found the book to be very helpful.The last chapters and appendixes are very helpful guides in developing how to writing styles for several types of reports. Not too in depth but a very good start for those who want to learn the writing style it takes to write several of these types of aggregate reports.Highly recommended as part of a drug safety professional's library of references for both new and experienced.This is one of the few books I would definitely recommend to have as a drug safety and pharmacovigilance professional.

If you are involved in or want to learn about drug safety analysis -- as clinician, statistician, writer, project manager -- this is a unique and valuable resource. It presents information logically and explains not just what but why and how. One of the best features is the in-depth sample integrated analysis of safety (IAS). This book provides an excellent understanding of benefit-risk analysis, safety profiles and more. I have worked in the pharmaceutical field for over 20 years, and I have recommended this to many people.

The cover of this book states Drug Safety Data but the content is Astrology. I bought this book in advance, classes just began and I can't use the book and even worse my window for returns is over. I am very disappointed!

Having recently taken on a new role in organizing Pharmacovigilance as well as outsourcing PV operations at a small Biotech, I found this book invaluable! It provides a very clear and realistic road map for drug safety including examples and clear guidelines for the processes required in meeting the myriad of drug safety regulations that are the reality within the Pharmaceutical/Biotech Industry. I cannot recommend this book highly enough for folks who are both new to the Industry and those with many years experience. We all have much to learn and this book has been an invaluable teacher to me despite my 20 + years of Industry experience. The key to its success is the simplicity with which it deals with and lays out the very complex world which is Pharmacovigilance.

I'm a solo medical director in a small company needing a "crash course" on drug safety monitoring before starting a new development project. When I first thumbed through this book it seemed deceptively simple but it has provided exactly the `how to' for pharmaceutical pharmacovigilance that I was looking for. The authors guidance on setting each component up systematically and with `the end in mind' is straight-forward enough to implement and should be a great time saver. Inexpensive - a good buy for virtually anyone (not just MDs) who doesn't specialize in this area of drug development.

This book is very well written. It's chapters are well organized, and the language used is straightforward (meaning not too technical). The authors provide easy to understand definitions and they support their opinions with sound, logical rationale as well as examples. Each chapter ends with a good, health set of citations for further reading. My background is nursing and I am fairly new to pharmacovigilance so the first set of chapters reinforce what I already know and provide rationale for processes/approaches that I have been asked to perform in my role as a drug safety specialist. I truly appreciate the examples and the narrative presented. I also respect that the authors note from time to time that "this is what we are calling it....you may call it something else, but the sentinal point is..." (paraphrasing). Each chapter is brief (a compliment to getting to the point) and presents its point(s) in a concise manner. In addition, the "voices" behind the words clearly express the importance on the patient and his/her safety. This book is a great resource to have on your shelf and/or to use with members of your organization. It is a great tool, a great resource. I believe this book is a must have.

Just what I was looking for! A concise `how to' guide written in a plain, friendly style that demystifies health authority regulations and guidelines. Although I have company SOPs to follow, this book can help me (with my nonclinical background working in Drug Safety for a pharmaceutical company) process incoming information and interpret large amounts of safety data far more intelligently. I am particularly impressed with the various examples of `real' safety compilations the authors use to illustrate theory.