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

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

ISBN-10:
0849314011
ISBN-13:
9780849314018
Pub. Date:
05/28/2003
Publisher:
Taylor & Francis

Hardcover

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Overview

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

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: 6.30(w) x 9.50(h) x 0.76(d)

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

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