Novel Therapeutics from Modern Biotechnology
Post, Leonard E. / Oxender, Dale L.
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 bio...
