Gad, Shayne Cox. 　著

内容

目次

Preface. 1.1 From Gene to Product: The Advantage of IntegrativeBiotechnology (Frank-Ranier Schmidt). 1.2 Sequencing the Human Genome: WasIt Worth It? (Eugene Zabarovsky). 1.3 Overview: Differentiating Issues inthe Development of Macromolecules Compared with Small Molecules (GuntherBlaich, Bernd Janssen, Gregory Roth, and Jochen Salfeld). 1.4 IntegratedDevelopment of Glycobiologics: From Discovery to Applications in the Designof Nanoparticular Drug Delivery Systems (Christine Vauthier, IsabelleBertholon, and Denis Labarre). 1.5 R&D Paradigm Shift andBillion-Dollar Biologics (Krishan Maggon). 2 From Defi ning Bioinformaticsand Pharmacogenomics to Developing Information-Based Medicine andPharmacotyping in Health Care (Ioannis S. Vizirianakis). 3.1Toxicogenomics (Mary Jane Cunningham and Mrinal Shah). 3.2 PreclinicalPharmacokinetics (Donald E. Mager and Murali Ramanthan). 3.3 Strategiesfor the Cytosolic Delivery of Macromolecules: An Overview (Aravind Asokan,Roland Cheung, and Moo J. Cho). 4.1 Basic Issues in the Manufacture ofMacromoleucles (Corinne Lengsfeld and Thomas Anchordoquy). 4.2 ProcessValidation for Biopharmaceuticals (Beth Junker). 4.3 Stability Assessmentand Formulation Characterization (Albert H.L. Chow, Henry H.Y. Tong, and YingZheng). 4.4 Protein Posttranslational Modifi cation: A Potential Target inPharmaceutical Development (M.D. Mostaqul Huq and Li-Na Wei). 4.5PEGylation: Camoufl age of Proteins, Cells, and Nanoparticles AgainstRecognition by the Body's Defense Mechanism (Yong Woo Cho, Jae Hyung Park, JiSun Park, and Kinam Park). 4.6 Unexpected Benefi ts of a Formulation: CaseStudy with Erythropoetin (David Keast). 5.1 Capillary SeparationTechniques (Dong Hee Na and Kang Choon Lee). 5.2 Pharmaceutical Bioassay(Jun Li, Ming Zhao, and Shiqi Peng). 5.3 Analytical Considerations forImmunoassays for Macromolecules (Marian Kelley and Binodh DeSilva). 5.4Chromatography-Based Separation of Proteins, Peptides, and Amino Acids (JanMoebius, Remco Swart, and Albert Sickman). 5.5 Bioanalytical MethodValidation for Macromolecules (Gerhard K.E. Scriba). 5.6 Microarrays inDrug Discovery and Development (Krishnanand D. Kumble and Sarita Kumble).5.7 Genetic Markers and Genotyping Analyses for Genetic Disease Studies (AnneE. Kwitek and Michael Olivier). 6.1 Proteins: Hormones, Enzymes, andMonoclonal\Antibodies-Background (Wayne Materi, Zoltan Gombos, and David S.Wishart). 6.2 Formulation and Delivery Issues of Therapeutic Proteins(Sathy V. Balu-Iyer, Razvan D. Miclea, and Vivek S. Purohit). 6.3Pharmacokinetics (Nobuhito Shibata, Yukato Ito, and Kanji Takada). 6.4Immunogenicity of Therapeutic Proteins (Suzanne Hermeling, Daan J.A.Crommelin, Huub Schellekens, and Wim Jiskoot). 6.5 Development andCharacterization of High-Affi nity Anti-Topotecan IgG and Fab Fragments (JinChen and Joseph P. Balthasar). 6.6 Recombinant Antibodies for PathogenDetection and Immunotherapy (Nicholas J. Pokorny, Jeanine I. Boulter-Bitzer,J. Chris Hall,Jack T. Trevors, and Hung Lee). 6.7 The RadiopharmaceuticalScience of Monoclonal Antibodies and Peptides for Imaging and Targeted insitu Radiotherapy of Malignancies (Raymond M. Reilly). 7.1 GeneTherapy-Basic Principles and the Road from Bench to Bedside (Gabor M.Rubanyi). 7.2 Plasmid DNA and Messenger RNA for Therapy (Steve Pascolo).7.3 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies(Tatiana Segura). 7.4 Pharmacokinetics of Nucleic-Acid-Based Therapeutics(John C. Schmitz, Aleksandra Pandyra, James Koropatnick, and Randal. W.Berg). 7.5 Case Studies-Development of Oligonucleotides (Ezharul HoqueChowdhury and Toshihiro Akaike). 7.6 RNA Interference: The NextGene-Targeted Medicine (Andrew V. Oleinikov and Matthew D. Gray). 7.7Delivery Systems for Peptides/Oligonucleotides and Lipophilic NucleosideAnalogs (R.A. Schwendener and Herbert Schott). 8.1 Growth Factors andCytokines (Mandeep K. Mann and Brian E. Cairns). 8.2 Growth Factors,Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics(Heping Cao and Rui Lin). 9 Protein Engineering with Noncoded Amino Acids:Applications to Hirudin (Vincenzo De Filippis). 10.1 Production and Purification of Adenovirus Vectors for Gene Therapy (D.M.F. Prazeres and J.A.L.Santos). 10.2 Assessing Gene Therapy by Molecular Imaging (Pascal Delepineand Claude Ferec). 11 Overview of Stem and Artifi cial Cells (AlejandroSoto-Gutierrez, Nalu Navarro-Alvarez, Jorge David Rivas-Carrillo, and NaoyaKobayashi). 12.1 Regulation of Small-Molecule Drugs Versus BiologicalsVersus Biotech Products (Maria de los Angeles Cortes Castillo and Jose LuisDi Fabio). 12.2 Intellectual Property and Biotechnology (Tania Bubela andKaren Lynne Durell). 12.3 Comparability Studies for Later-GenerationProducts-Plant-Made Pharmaceuticals (Patrick A. Stewart). 12.4 Biosimilars(H. Schellekens, W. Jiskoot, and D.J.A. Crommelin). 13.1 The Promise ofIndividualized Therapy (Michael Oettel). 13.2 Enhanced Proteomic Analysisby HPLC Prefractionation (Pierre C. Havugimana, Peter Wong, and AndrewEmili). 13.3 An Overview of Metabonomics Techniques and Applications (JohnC. Lindon). 13.4 Bioterrorism (Dany Shoham). Index.