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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.
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