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.
General
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