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.
Table of Contents
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
General Regulations for Drugs and Biological Products
Center for Drug Evaluation and Research (CDER), List of Important Guidelines
"In this age of rapid changes it has become almost impossible to write a book which is up to date with the most recent changes. Nevertheless, the book succeeds in giving a broad and solid account of the subject and gives a reader without a strong background in the area a good introduction into the field in a very concise and well-structured way."
- Pharmaceutical Research
"[T]he appendix contains helpful information regarding general regulations for drugs and biological products. The text contains numerous black and white tables and figures that compliment and greatly enhance the text and make understanding the organisation and workings of the FDA more comprehensible. … [A]n excellent introductory treatise in regulatory approval of drugs. … [A]n excellent text, which achieves its goals, and would be a useful addition to any toxicology or pathology department's reference library."
- BTS Newsletter, Summer 2004, Issue 24