Title: Development and evaluation of drugs : from laboratory through licensure to market /
Authors: Lee, Chi-Jen.; Lee, Lucia H.; Lü, Zhengxiong.
Publisher: CRC Press,
Year: 2003
Subjects: Legislation, Pharmacy; Drug Evaluation; Drug Design; Drug Industry; Drug development.; Drugs Testing.; Drugs Law and legislation United States.; Pharmaceutical industry.; United States; United States
Contents: 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.