| Edition |
Second edition. |
| Description |
1 online resource (xiv, 241 pages) : illustrations |
| 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 |
| Bibliography |
Includes bibliographical references and index. |
| Note |
Description based on print version record. |
| Summary |
Since the initial publication of Development and Evaluation Drugs from Laboratory through Licensure to Market in 1993, many changes have occurred in biomedicine, biotechnology, pharmaceutical science and technology, and drug evaluation systems. Updated and expanded, this second edition examines all of the recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. Discussions include hot topics such as genome structure, rational drug design, good manufacturing practices, bioavailability and bioequivalence, and P. |
| Note |
GMD: electronic resource. |
| Subject |
Drug development.
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Drugs -- Testing.
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Drugs -- Law and legislation -- United States.
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Pharmaceutical industry.
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Drug Industry -- United States.
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Drug Design -- United States.
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Drug Evaluation -- United States.
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Legislation, Pharmacy -- United States.
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| Added Author |
Lee, Lucia H.
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Lü, Zhengxiong.
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| Other Form: |
Print version: Lee, Chi-Jen. Development and evaluation of drugs. 2nd ed. Boca Raton : CRC Press, c2003 0849314011 (DLC) 2003041011 (OCoLC)51446021 |
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