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

----- 药物开发与评价

ISBN: 9780849314018 出版年：2003 页码：258 Lee, Chi Jen Lu, Cheng-Hsiung Lee, Lucia H CRC Press

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