Development and Evaluation of Drugs: From Laboratory through Licensure to Market / Edition 2

by Chi-Jen Lee

Overview

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Product Details

ISBN-13:	9780849314018
Publisher:	Taylor & Francis
Publication date:	05/28/2003
Edition description:	REV
Pages:	256
Product dimensions:	6.12(w) x 9.19(h) x (d)

About the Author

Chi Jen Lee, Cheng-Hsiung Lu, Lucia H. Lee

Table of Contents

INTRODUCTION. Interdisciplinary Sciences for Drug Discovery. The Search for Health - A Dream of Conquering Disease. Drug Development in the Biotechnology Era. DRUG EVALUATION FROM LABORATORY THROUGH LICENSURE TO PHARMACIST'S SHELF. Drug Evaluation Process and Licensure. Quality Assurance-Regulation and Control Tests. References. PRACTICAL ASPECTS OF DRUG EVALUATION AND RESPONSE. Generic Drugs and Orphan Drugs. Pharmacokinetic Models for Drug Absorption. Factors Affecting Response to Drugs. Mechanisms of Drug Interaction. Adverse Drug Reactions. Pregnancy and Lactation. DEVELOPMENT OF NEW DRUG BY RESEARCH INSTITUTES AND THE PHARMACEUTICAL INDUSTRY. Medical and Pharmaceutical Research in Drug Development. Challenges in Preclinical Drug Testing. Strategies and Planning for Clinical Trials - Good Clinical practice (GCP). Pharmaceutics and Drug Delivery System. Regulatory Issues Involved in Plant Medicines. CHALLENGING PROBLEMS FOR THE FUTURE. A Pursuit of Healthy and Happy Life in an Aging Society. Aspects of Current Biomedical Research. The High Costs of Health Care and Drug Development. Drug Safety and Global Health. Scientific Advances to Revolutionize Modern Medicine. References.

Editorial Reviews

"In this age of rapid changes it has become almost impossible to write a book which is up to date with the most recent changes. Nevertheless, the book succeeds in giving a broad and solid account of the subject and gives a reader without a strong background in the area a good introduction into the field in a very concise and well-structured way."
- Pharmaceutical Research


"[T]he appendix contains helpful information regarding general regulations for drugs and biological products. The text contains numerous black and white tables and figures that compliment and greatly enhance the text and make understanding the organisation and workings of the FDA more comprehensible. … [A]n excellent introductory treatise in regulatory approval of drugs. … [A]n excellent text, which achieves its goals, and would be a useful addition to any toxicology or pathology department's reference library."
- BTS Newsletter, Summer 2004, Issue 24


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From the Publisher

2 Stars from Doody

Reviewer: Amy Morikado, RPh, MS (Caremark Inc.)
Description: This book intends to describe the drug development process from discovery through the postmarketing surveillance of a product.
Purpose: The purpose is to explore the development and evaluation of drugs, explain the regulatory process, and analyze practical problems of the pharmaceutical industry.
Audience: Although the target audience for this book is pharmaceutical scientists, much of the information presented is very basic and common knowledge to those working in the field of pharmaceuticals. Most of this book was written at the level of a layperson.
Features: This book was formatted with wide margins, and much of it is written in outline format, which makes it difficult to follow. The figures are compiled at the end of each chapter instead of within the text, also making this book cumbersome to read. The regulatory process for drug development in the United States is described as well as the regulatory process in Japan; however, no references are made to the European community, where many of the clinical trials are conducted. References areappropriate and adequate, and the table of contents and index are easy to follow.
Assessment: The scope of this book is too general to be of any practical use to pharmaceutical scientists. An emphasis on the regulatory process would have been more useful.

Doody's Review Service