Development and Evaluation of Drugs: From Laboratory through Licensure to Market, 2nd Edition (Hardback) book cover

Development and Evaluation of Drugs

From Laboratory through Licensure to Market, 2nd Edition

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

CRC Press

256 pages | 16 B/W Illus.

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Description

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.

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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Table of Contents

INTRODUCTION

Discovery and Development of Drugs

The Search for Health - A Dream to Conquer 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

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

DEVELOPMENT OF NEW DRUGS 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 Pharmaceutics and Drug Delivery System

Regulatory Issues Involved in Plant Medicines

CHALLENGING PROBLEMS IN THE FUTURE

Pursuit of a Healthy and Happy Life in an Aging Society

Aspects of Current Biomedical Research

High Costs of Health Care and Drug Development

Drug Safety and Global Health

Scientific Advances to Revolutionize Modern Medicine

APPENDIX

General Regulations for Drugs and Biological Products

Center for Drug Evaluation and Research (CDER), List of Important Guidelines

INDEX

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology