This new edition reflects the many changes that have taken place in biomedicine, biotechnology, pharmaceutical science and technology since the first edition in 1993. It discusses topics such as genome structure, rational drug design, good manufacturing processes and bioavailability. "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 24Promo Copy