Foreword.
Preface.
Organization of the Book.
Contributors.
PART I: TRANSFORMING PROTEINS AND GENES INTO THERAPEUTICS.
Introduction to Biopharmaceuticals.
Comparative Drug Development of Proteins and Genes versus Small Molecules.
Biotechnology Industry Perspective on Drug Development.
Biopharmaceutical Technologies and Processes in Drug Development.
Pharmacology, Toxicology, Therapeutic Dosage Formulations, and Clinical Response.
PART II: THERAPEUTICS BASED ON BIOTECHNOLOGY.
Hematopoietic Growth Factors and Coagulation Factors.
Interferons and Cytokines for Anti-Infective and Cancer Therapy.
Hormones.
Enzymes.
Antibodies and Derivatives.
Vaccines.
Other Products: Monographs.
PART III: FUTURE DIRECTIONS.
Advanced Drug Delivery.
Individualization of Drug Regimens: Integration of Pharmacokinetic and Pharmacogenetic Principles in Drug Therapy.
Gene and Cell Therapy.
Integration of Discovery and Development: The Role of Genomics and Proteomics.
Appendix I. Dosage Form, Pharmacokinetics, and Disposition Data.
Appendix II. Molecular Characteristic and Therapeutic Use.
Appendix III. Nomenclature of Biotechnology Products.
Appendix IV. Synonym of Trade, Common, and Scientific Names.
Appendix V. Other Information Tables.
Index.
Monographs Index.
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