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Many iterations are carried out, and the leading compounds are modiﬁed and synthesized to improve their interactions with the targets, to reduce toxicity, or to improve pharmacokinetic performance.At the end of this process, an optimized compound is found and this becomes a potential drug ready for clinical trial in humans.Wiley also publishes its books in a variety of electronic formats. Even persons from seemingly disparate occupations, such AN OVERVIEW OF THE DRUG DISCOVERY AND DEVELOPMENT PROCESS 3 Figure 1.1 The stages from drug discovery to marketing approval.
At the end of each chapter is a case study to provide more in-depth perspectives and current issues facing the pharmaceutical industry. Of importance is the role of regulatory authorities in these processes.Published by John Wiley & Sons, Inc., Hoboken, New Jersey. No part of this publication may be reproduced, stored in retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 750-4470, or on the web at It should be noted that the descriptions in this book on discovery and regulatory processes are mainly for ethical drugs, as opposed to over-the-counter (OTC) drugs.Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at Ethical drugs require prescriptions by physicians, whereas OTC drugs can be purchased from pharmacies without prescriptions. In this context, toxins and poisons can be classiﬁed as drugs. To establish a frame of reference, it is appropriate to commence with a deﬁnition for the term “drug.” Generally, a drug can be deﬁned as a substance that induces a response within the human body, whether the response is beneﬁcial or harmful.