DESCRIPTION:
This introductory text explains both the basic science, production, quality, dosage forms, administration, economic and regulatory aspects and the clinical applications of biotechnology-derived pharmaceuticals. It serves as a complete one-stop source for undergraduate/graduate pharmacists and pharmaceutical science students. An additional important audience are pharmaceutical scientists in industry and academia, particularly those who have not received formal training in pharmaceutical biotechnology and are inexperienced in this field.
The rapid growth and advances in the field made it necessary to revise this textbook in order to continue providing up-to-date information and introduce readers to cutting edge knowledge and technology of this field. This Sixth Edition completely updates the previous edition and includes additional coverage on new approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies and vaccines. With more than 3-million-chapter downloads, the fifth edition of the textbook has achieved widespread distribution as a key educational resource for the field of pharmaceutical biotechnology.
CONTENTS:
Pharmaceutical Biotechnology: The Science, Techniques, and Important Concepts
Molecular Biotechnology: From DNA Sequence to Therapeutic Protein
Biophysical and Biochemical Characteristics of Therapeutic Proteins
Stability and Characterization of Protein- and Nucleotide-Based Therapeutics
Production and Purification of Recombinant Proteins
Formulation of Biologics Including Biopharmaceutical Considerations
Pharmacokinetics and Pharmacodynamics of Therapeutic Proteins and Nucleic Acids
Immunogenicity of Therapeutic Proteins
Monoclonal Antibodies: From Structure to Therapeutic Application
Genomics, Other "OMIC" Technologies, Precision Medicine, and Additional Biotechnology-Related Techniques
Economic Considerations in Medical Biotechnology
Biosimilars: Principles, Regulatory Framework, and Societal Aspects
An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications
Pharmaceutical Biotechnology: Oligonucleotides, Genes and Cells/Cell Subunits, Vaccines_The Science, Techniques, and Clinical Use
Oligonucleotides and mRNA Therapeutics
Advanced Therapy Medicinal Products: Clinical, Non-clinical, and Quality Considerations
Vaccines
Pharmaceutical Biotechnology: The Protein Products of Biotechnology and Their Clinical Use_Endogenous Proteins and Their Variations
Insulin
Hematopoietic Growth Factors
Recombinant Coagulation Factors and Thrombolytic Agents
Follicle-Stimulating Hormone
Human Growth Hormone
Recombinant Human Deoxyribonuclease I
Interferons and Interleukins
Pharmaceutical Biotechnology: The Protein Products of Biotechnology and Their Clinical Use_Monoclonal Antibodies and Their Variations
Antibody-Based Biotherapeutics in Cancer
Antibody-Based Biotherapeutics in Inflammatory Diseases
Monoclonal Antibodies in Solid Organ Transplantation
Antibody-Based Biotherapeutics in Migraine
