The rapid advances in recombinant DNA technology and the
increasing availability of peptides and proteins with therapeutic
potential are a challenge for pharmaceutical scientists who have to
formulate these compounds as drug products.
Pharmaceutical Formulation Development of Peptides and Proteins,
Second Edition discusses the development of therapeutic peptides
and proteins, from the production of active compounds via basic
pre-formulation and formulation to the registration of the final
product.
Providing integrated solutions, this book discusses:
- The synthesis of peptides and the biotechnological production
of proteins through recombinant DNA technology
- The physicochemical characteristics and stability of peptides
and proteins
- The formulation of proteins as suspensions, solutions, and
(mostly freeze-dried) solids
- The opportunities and challenges of non-parenteral delivery of
peptides and proteins
- Risk factors, specifically the development of an unwanted
immune response
- A simulation approach to describe the fate of peptides and
proteins upon administration to a biological system
- The documentation required to register a protein-based
drug
Scientists in the pharmaceutical industry and academia as well
as postgraduate students in pharmaceutical science will find this a
valuable resource.
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