This volume addresses the particular problems associated with several classes of biotechnology products, and at the same time demonstrates that the principles are the same as in the development of small new chemical entities. The first chapter addresses FDA regulatory expectations for biotech products. The next several chapters discuss general issues common to each class of biotech drug such as proteins, peptides, and nucleic acids. The balance of the chapters deal with specific biotech drugs that have successfully made it into clinical trials. The reviews are written by renowned experts in their fields.

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.