Full 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.
Contents
INTRODUCTION. Interdisciplinary Sciences for Drug Discovery. The Search for Health - A Dream of Conquering 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. References. 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. Pregnancy and Lactation. DEVELOPMENT OF NEW DRUG 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 - Good Clinical practice (GCP). Pharmaceutics and Drug Delivery System. Regulatory Issues Involved in Plant Medicines. CHALLENGING PROBLEMS FOR THE FUTURE. A Pursuit of Healthy and Happy Life in an Aging Society. Aspects of Current Biomedical Research. The High Costs of Health Care and Drug Development. Drug Safety and Global Health. Scientific Advances to Revolutionize Modern Medicine. References.
