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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.

Some content that appears in print may not be available in electronic format. as economists, lawyers, and regulatory staff, play a vital role as well.

A summary of important points and questions and answers are added to each chapter for reference. Through Drugs: From Discovery to Approval, Second Edition, By Rick Ng Copyright © 2009 John Wiley & Sons, Inc.

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Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Readers are referred to Appendix 1 for a brief description of the history of drug development since ancient times.

For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at (800) 762-2974, outside the United States at (317) 572-3993 or fax (317) 572-4002. Today, personnel from a myriad of fields are involved in the process of drug discovery and development, from scientists, clinicians, and medical practitioners to statisticians.

The reason for this is that drug discovery and development has made a quantum leap forward in recent times with progress in genomics/proteomics and biotechnology.

In addition, advances in laboratory equipment automation and high-speed computing have assisted in analyzing and processing large data sets.

Clinical Trials: These are trials conducted on human subjects.

The pertinent parameters for clinical trials are protocols (methods about how trials are to be conducted), safety and respect for human subjects, responsibilities of the investigator, institutional review board, informed consent, trial monitoring, and adverse event reporting.

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.

For information about Wiley products, visit our web site at Previously, the main scientific personnel in the discovery process have been synthetic chemists.

Library of Congress Cataloging-in-Publication Data: Ng, Rick. Now molecular biologists, biochemists, microbiologists, engineers, and even computer scientists play equally important roles in the drug discovery and development processes.

The advice and strategies contained herein may not be suitable for your situation. Most of the descriptions in this book apply to new drugs.

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