05288nam 2200673Ia 450 991082729400332120240410142814.01-280-90013-X97866109001380-470-11711-70-470-11710-9(CKB)1000000000355944(EBL)297254(OCoLC)159953950(SSID)ssj0000168073(PQKBManifestationID)11184170(PQKBTitleCode)TC0000168073(PQKBWorkID)10179228(PQKB)10374165(MiAaPQ)EBC297254(Au-PeEL)EBL297254(CaPaEBR)ebr10278152(CaONFJC)MIL90013(PPN)137628137(EXLCZ)99100000000035594420060918h20072007 uy 0engurcn|||||||||txtrdacontentcrdamediacrrdacarrierHandbook of pharmaceutical biotechnology /edited by Shayne Cox Gad1st ed.Hoboken, N.J. :Wiley-Interscience,2007.©20071 online resource (xix, 1659 pages) illustrationsPharmaceutical Development Series ;v.20-471-21386-1 Includes bibliographical references and index.HANDBOOK OF PHARMACEUTICAL BIOTECHNOLOGY; CONTRIBUTORS; CONTENTS; Preface; 1.1 From Gene to Product: The Advantage of Integrative Biotechnology; 1.2 Sequencing the Human Genome: Was It Worth It?; 1.3 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules; 1.4 Integrated Development of Glycobiologics: From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems; 1.5 R&D Paradigm Shift and Billion-Dollar Biologics2 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care 3.1 Toxicogenomics; 3.2 Preclinical Pharmacokinetics; 3.3 Strategies for the Cytosolic Delivery of Macromolecules: An Overview; 4.1 Basic Issues in the Manufacture of Macromoleucles; 4.2 Process Validation for Biopharmaceuticals; 4.3 Stability Assessment and Formulation Characterization; 4.4 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development4.5 PEGylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism 4.6 Unexpected Benefits of a Formulation: Case Study with Erythropoetin; 5.1 Capillary Separation Techniques; 5.2 Pharmaceutical Bioassay; 5.3 Analytical Considerations for Immunoassays for Macromolecules; 5.4 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids; 5.5 Bioanalytical Method Validation for Macromolecules; 5.6 Microarrays in Drug Discovery and Development; 5.7 Genetic Markers and Genotyping Analyses for Genetic Disease Studies6.1 Proteins: Hormones, Enzymes, and Monoclonal\Antibodies-Background 6.2 Formulation and Delivery Issues of Therapeutic Proteins; 6.3 Pharmacokinetics; 6.4 Immunogenicity of Therapeutic Proteins; 6.5 Development and Characterization of High-Affinity Anti-Topotecan IgG and Fab Fragments; 6.6 Recombinant Antibodies for Pathogen Detection and Immunotherapy; 6.7 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies; 7.1 Gene Therapy-Basic Principles and the Road from Bench to Bedside7.2 Plasmid DNA and Messenger RNA for Therapy 7.3 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies; 7.4 Pharmacokinetics of Nucleic-Acid-Based Therapeutics; 7.5 Case Studies-Development of Oligonucleotides; 7.6 RNA Interference: The Next Gene-Targeted Medicine; 7.7 Delivery Systems for Peptides/Oligonucleotides and Lipophilic Nucleoside Analogs; 8.1 Growth Factors and Cytokines; 8.2 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics; 9 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin; 10.1 Production and Purification of Adenovirus Vectors for Gene TherapyA practical overview of a full range of 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: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations andPharmaceutical Development SeriesPharmaceutical biotechnologyHandbooks, manuals, etcPharmaceutical chemistryPharmaceutical biotechnologyPharmaceutical chemistry.615/.19Gad Shayne C.1948-96171MiAaPQMiAaPQMiAaPQBOOK9910827294003321Handbook of pharmaceutical biotechnology3994137UNINA