Download or read book Novel Therapeutics from Modern Biotechnology written by Dale L. Oxender and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.