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

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

Product Details

ISBN-13:	9781135510244
Publisher:	CRC Press
Publication date:	05/28/2003
Sold by:	Barnes & Noble
Format:	eBook
Pages:	256
File size:	2 MB

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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