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[½»Á÷] Development and Evaluation of Drugs ...

Title: Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition
Author: Chi-Jen Lee
Publisher: CRC
Publication Date: 2003-05-28
Number Of Pages: 256

Review
"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 Promo Copy

Book Description
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

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