| Description |
1 online resource (258 pages) |
| Contents |
Front Cover; FOREWORD*; PREFACE; THE AUTHORS; CONTENTS; Chapter 1; INTRODUCTION; I. DISCOVERY AND DEVELOPMENT OF DRUGS; II. SEARCH FOR HEALTH -- A DREAMTO CONQUER DISEASES; III. DRUG DEVELOPMENT IN THE BIOTECHNOLOGY ERA; REFERENCES; Chapter 2; DRUG EVALUATION FROM LABORATORY THROUGH LICENSURE TO PHARMACIST'S SHELF; I. DRUG EVALUATION PROCESS AND LICENSURE; II. QUALITY ASSURANCE -- REGULATION AND CONTROL TESTS; REFERENCES; Chapter 3; PRACTICALASPECTS OF DRUG EVALUATION AND RESPONSE; I. GENERIC AND ORPHAN DRUGS; II. PHARMACOKINETIC MODELS FOR DRUG ABSORPTION; III. FACTORS AFFECTING DRUG RESPONSE |
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IV. MECHANISMS OF DRUG INTERACTIONV. ADVERSE DRUG REACTIONS; REFERENCES; Chapter 4; DEVELOPMENT OF NEW DRUGS BY RESEARCH INSTITUTES AND THE PHARMACEUTICAL INDUSTRY; I. MEDICAL AND PHARMACEUTICAL RESEARCH IN DRUG DEVELOPMENT; II. CHALLENGES IN PRECLINICAL DRUG TESTING; III. STRATEGIES AND PLANNING FOR CLINICAL TRIALS; IV. PHARMACEUTICS AND THE DRUG DELIVERY SYSTEM; V. REGULATORY ISSUES INVOLVED IN PLANT MEDICINES32-34; REFERENCES; Chapter 5; CHALLENGING PROBLEMS IN THE FUTURE; I. PURSUIT OF A HEALTHY AND HAPPY LIFE IN AN AGING SOCIETY; II. ASPECTS OF CURRENT BIOMEDICAL RESEARCH |
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III. HIGH COSTS OF HEALTH CARE AND DRUG DEVELOPMENTIV. DRUG SAFETY AND GLOBAL HEALTH; V. SCIENTIFIC ADVANCES TO REVOLUTIONIZE MODERN MEDICINE; REFERENCES; APPENDIX; I. GENERAL REGULATIONS FOR DRUGS AND BIOLOGICAL PRODUCTS; II. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), LIST OF IMPORTANT GUIDELINES; INDEX; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z; Back Cover |
| Summary |
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 intrinsica |
| Notes |
Print version record |
| Subject |
Drug development.
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Drugs -- Law and legislation -- United States
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Drugs -- Testing.
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Pharmaceutical industry.
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Clinical Trials as Topic
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Drug Industry
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Drugs -- Law and legislation
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Drug development
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Drugs -- Testing
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Pharmaceutical industry
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United States
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| Form |
Electronic book
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| Author |
Lu, Cheng-Hsiung
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Lee, Lucia H
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| ISBN |
9781135510251 |
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1135510253 |
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