Handbook of Pharmaceutical BiotechnologyShayne Cox Gad John Wiley & Sons, 2007 M05 23 - 1680 pages A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference:
With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry. |
Contents
| 53 | |
| 89 | |
| 125 | |
15 RD Paradigm Shift and BillionDollar Biologics | 161 |
2 From Defining Bioinformatics and Pharmacogenomics to Developing InformationBased Medicine and Pharmacotyping in Health Care | 201 |
31 Toxicogenomics | 229 |
32 Preclinical Pharmacokinetics | 253 |
33 Strategies for the Cytosolic Delivery of Macromolecules An Overview | 279 |
66 Recombinant Antibodies for Pathogen Detection and Immunotherapy | 851 |
67 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies | 883 |
71 Gene TherapyBasic Principles and the Road from Bench to Bedside | 943 |
72 Plasmid DNA and Messenger RNA for Therapy | 971 |
73 Formulations and Delivery Limitations of NucleicAcidBased Therapies | 1013 |
74 Pharmacokinetics of NucleicAcidBased Therapeutics | 1061 |
75 Case StudiesDevelopment of Oligonucleotides | 1087 |
76 RNA Interference The Next GeneTargeted Medicine | 1109 |
41 Basic Issues in the Manufacture of Macromoleucles | 297 |
42 Process Validation for Biopharmaceuticals | 319 |
43 Stability Assessment and Formulation Characterization | 371 |
44 Protein Posttranslational Modification A Potential Target in Pharmaceutical Development | 417 |
45 PEGylation Camouflage of Proteins Cells and Nanoparticles Against Recognition by the Bodys Defense Mechanism | 443 |
46 Unexpected Benefits of a Formulation Case Study with Erythropoetin | 463 |
51 Capillary Separation Techniques | 469 |
52 Pharmaceutical Bioassay | 511 |
53 Analytical Considerations for Immunoassays for Macromolecules | 573 |
54 ChromatographyBased Separation of Proteins Peptides and Amino Acids | 585 |
55 Bioanalytical Method Validation for Macromolecules | 611 |
56 Microarrays in Drug Discovery and Development | 633 |
57 Genetic Markers and Genotyping Analyses for Genetic Disease Studies | 661 |
61 Proteins Hormones Enzymes and MonoclonalAntibodiesBackground | 691 |
62 Formulation and Delivery Issues of Therapeutic Proteins | 737 |
63 Pharmacokinetics | 757 |
64 Immunogenicity of Therapeutic Proteins | 815 |
65 Development and Characterization of HighAffinity AntiTopotecan IgG and Fab Fragments | 835 |
77 Delivery Systems for PeptidesOligonucleotides and Lipophilic Nucleoside Analogs | 1149 |
81 Growth Factors and Cytokines | 1173 |
82 Growth Factors Cytokines and Chemokines Formulation Delivery and Pharmacokinetics | 1197 |
9 Protein Engineering with Noncoded Amino Acids Applications to Hirudin | 1225 |
101 Production and Purification of Adenovirus Vectors for Gene Therapy | 1261 |
102 Assessing Gene Therapy by Molecular Imaging | 1297 |
11 Overview of Stem and Artificial Cells | 1313 |
121 Regulation of SmallMolecule Drugs Versus Biologicals Versus Biotech Products | 1373 |
122 Intellectual Property and Biotechnology | 1391 |
123 Comparability Studies for LaterGeneration ProductsPlantMade Pharmaceuticals | 1433 |
124 Biosimilars | 1453 |
131 The Promise of Individualized Therapy | 1463 |
132 Enhanced Proteomic Analysis by HPLC Prefractionation | 1491 |
133 An Overview of Metabonomics Techniques and Applications | 1503 |
134 Bioterrorism | 1525 |
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Common terms and phrases
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