LEADER 05263nam 2200661Ia 450 001 9910827294003321 005 20200520144314.0 010 $a1-280-90013-X 010 $a9786610900138 010 $a0-470-11711-7 010 $a0-470-11710-9 035 $a(CKB)1000000000355944 035 $a(EBL)297254 035 $a(OCoLC)159953950 035 $a(SSID)ssj0000168073 035 $a(PQKBManifestationID)11184170 035 $a(PQKBTitleCode)TC0000168073 035 $a(PQKBWorkID)10179228 035 $a(PQKB)10374165 035 $a(MiAaPQ)EBC297254 035 $a(Au-PeEL)EBL297254 035 $a(CaPaEBR)ebr10278152 035 $a(CaONFJC)MIL90013 035 $a(PPN)137628137 035 $a(EXLCZ)991000000000355944 100 $a20060918d2007 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aHandbook of pharmaceutical biotechnology /$fedited by Shayne Cox Gad 205 $a1st ed. 210 $aHoboken, N.J. $cWiley-Interscience$dc2007 215 $a1 online resource (xix, 1659 pages) $cillustrations 225 1 $aPharmaceutical Development Series ;$vv.2 311 0 $a0-471-21386-1 320 $aIncludes bibliographical references and index. 327 $aHANDBOOK 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 Biologics 327 $a2 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 Development 327 $a4.5 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 Studies 327 $a6.1 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 Bedside 327 $a7.2 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 Therapy 330 $aA practical overview of a full range of approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and 410 0$aPharmaceutical Development Series 606 $aPharmaceutical biotechnology$vHandbooks, manuals, etc 606 $aPharmaceutical chemistry 615 0$aPharmaceutical biotechnology 615 0$aPharmaceutical chemistry. 676 $a615/.19 701 $aGad$b Shayne C.$f1948-$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910827294003321 996 $aHandbook of pharmaceutical biotechnology$93994137 997 $aUNINA