Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition

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 Phase IV post-marketing monitoring, and the final chapter explores future challenges. 1. Introduction -- I. Discovery And Development Of Drugs -- Ii. Search For Health: A Dream To Conquer Diseases -- Iii. Drug Development In The Biotechnology Era -- 2. Drug Evaluation From Laboratory Through Licensure To Pharmacist's Shelf -- I. Drug Evaluation Process And Licensure -- Ii. Quality Assurance: Regulation And Control Tests -- 3. Practical Aspects Of Drug Evaluation And Response -- I. Generic And Orphan Drugs -- Ii. Pharmacokinetic Models For Drug Absorption -- Iii. Factors Affecting Drug Response -- Iv. Mechanisms Of Drug Interaction -- V. Adverse Drug Reactions -- 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 Medicines -- 5. Challenging Problems In The Future -- I. Pursuit Of A Healthy And Happy Life In An Aging Society -- Ii. Aspects Of Current Biomedical Research -- Iii. High Costs Of Health Care And Drug Development -- Iv. Drug Safety And Global Health -- V. Scientific Advances To Revolutionize Modern Medicine -- Appendix I. General Regulations For Drugs And Biological Products -- Appendix Ii. Center For Drug Evaluation And Research (cder), List Of Important Guidelines. Chi-jen Lee, Lucia H. Lee, Cheng-hsiung Lu. Includes Bibliographical References And Index. 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. Many drugs in use today have been known for hundreds or thousands of years.