Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

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Published by

World Scientific Publishing Co. Pte. Ltd.

5 Toh Tuck Link, Singapore 596224

USA office: 27 Warren Street, Suite 401-402, Hackensack, NJ 07601

UK office: 57 Shelton Street, Covent Garden, London WC2H 9HE

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library.

COBERT’S MANUAL OF DRUG SAFETY AND PHARMACOVIGILANCE 3rd Edition

All rights reserved. This book, or parts thereof, may not be reproduced in any form or by any means, electronic or mechanical, including photocopying, recording or any information storage and retrieval system now known or to be invented, without written permission from the publisher.

For photocopying of material in this volume, please pay a copying fee through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA. In this case permission to photocopy is not required from the publisher.

ISBN 978-981-3278-84-4

For any available supplementary material, please visit

https://www.worldscientific.com/worldscibooks/10.1142/11228#t=suppl

Typeset by Stallion Press

Email: [email protected]

Printed in Singapore

Thank You

Thanks to Chris Davis who saw enough merit in the first edition to publish a second edition and now a third edition. And thank you to Sandhya Devi MG and her team at World Publishing. Great to work with all of you!

Thanks to our many colleagues in the drug safety world for their advice and clarification.

Thank you to Dr. Lisa Beth Ferstenberg for her excellent chapter on vaccines and to Dr. Germano Ferreira for his review of the mathematics and epidemiology chapters.

Barton Cobert: Thanks to Bill and Jean-Loup for taking much of the work and pressure off my shoulders!

And again thanks to my loving and lovely wife Josiane for tolerating my hours in front of the computer.

Jean-Loup Thomas: Thanks to all my colleagues and ex-colleagues who have been so professional and nice to work with.

William Gregory: To Lauren and Carly for their incredible love, for giving me a sharper appreciation of lawyers and veterinarians, and for making my soul blossom every day. To my co-authors for being so smart and easy to work alongside, chapter by chapter.

Chapter 1The Theory and Definitions of Drug Safety — Pharmacovigilance

The Theory

Adverse Event (AE) — ICH

Adverse Event (AE) — EMA

Adverse Event/Experience (AE) — FDA

Adverse Reaction (AR)

Serious Adverse Event and Serious Adverse Reaction (SAE/SAR)

Non-serious Adverse Event and Non-serious Adverse Reaction (NSAE/NSAR)