Preclinical safety evaluation of biopharmaceuticals : a science-based approach to facilitating clinical trials (Englisch)
- Neue Suche nach: Cavagnaro, Joy A.
2008
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ISBN:
- Report / Print
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Titel:Preclinical safety evaluation of biopharmaceuticals : a science-based approach to facilitating clinical trials
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Beteiligte:
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Verlag:
- Neue Suche nach: Wiley
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Erscheinungsort:Hoboken, NJ
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Erscheinungsdatum:2008
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Format / Umfang:XXVI, 1033 S., [4] Bl.
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Anmerkungen:25cm
Ill., graph. Darst.
Formerly CIP
Includes bibliographical references and index -
ISBN:
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Medientyp:Report
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Format:Print
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Sprache:Englisch
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Reportnr. / Förderkennzeichen:2007050275
- Neue Suche nach: 615.19
- Weitere Informationen zu Dewey Decimal Classification
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Schlagwörter:
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Klassifikation:
DDC: 615.19 -
Datenquelle:
Inhaltsverzeichnis E-Book
Die Inhaltsverzeichnisse werden automatisch erzeugt und basieren auf den im Index des TIB-Portals verfügbaren Einzelnachweisen der enthaltenen Beiträge. Die Anzeige der Inhaltsverzeichnisse kann daher unvollständig oder lückenhaft sein.
- 1
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Biopharmaceuticals: Definition and RegulationTsang, Lincoln / Cortez, Nathan et al. | 2008
- 21
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Methods of Production of Biopharmaceutical Products and Assessment of Environmental ImpactWilliams, Patricia D. et al. | 2008
- 43
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The Principles of ICH S6 and the Case‐by‐Case ApproachCavagnaro, Joy A. et al. | 2008
- 67
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Implementation of ICH S6: EU PerspectiveRyle, Peter R. / Snodin, David J. et al. | 2008
- 93
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Implementation of ICH S6: Japanese PerspectiveNakazawa, Takahiro et al. | 2008
- 111
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Implementation of ICH S6: US PerspectiveCosenza, Mary Ellen et al. | 2008
- 123
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Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and CostsHorvath, Christopher et al. | 2008
- 161
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Demonstration of Comparability of a Licensed Product after a Manufacturing ChangeLewis, Richard M. et al. | 2008
- 179
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Selection of Relevant SpeciesSubramanyam, Meena / Rinaldi, Nicola / Mertsching, Elisabeth / Hutto, David et al. | 2008
- 207
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Tissue Cross‐Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity TestingHall, William C. / Price‐Schiavi, Shari A. / Wicks, Joan / Rojko, Jennifer L. et al. | 2008
- 241
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Physiologic IgG Biodistribution, Transport, and Clearance: Implications for Monoclonal Antibody ProductsRojko, Jennifer L. / Price‐Schiavi, Shari et al. | 2008
- 277
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The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant SpeciesGreen, Martin D. / Hartsough, Melanie et al. | 2008
- 293
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Use of Animal Models of Disease in the Preclinical Safety Evaluation of BiopharmaceuticalsKoppele, Johan te / Witkamp, Renger et al. | 2008
- 309
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Safety Pharmacology: Similarities and Differences between Small Molecules and Novel BiopharmaceuticalsBernton, Edward W. et al. | 2008
- 337
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Genetic Toxicology Testing of BiopharmaceuticalsJacobson‐Kram, David / Ghantous, Hanan et al. | 2008
- 343
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General Toxicity Testing and Immunotoxicity Testing for BiopharmaceuticalsBussiere, Jeanine L. et al. | 2008
- 357
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Reproductive Toxicity Testing for BiopharmaceuticalsMartin, Pauline L. et al. | 2008
- 379
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Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman PrimatesWeinbauer, Gerhard F. / Frings, Werner / Fuchs, Antje / Niehaus, Michael / Osterburg, Ingrid et al. | 2008
- 399
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Preclinical Evaluation of Cancer Hazard and Risk of BiopharmaceuticalsCavagnaro, Joy A. et al. | 2008
- 475
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Immunogenicity of Therapeutic Proteins and the Assessment of RiskSchellekens, Huub / Jiskoot, Wim et al. | 2008
- 487
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Assessment of Autoimmunity and HypersensitivityDescotes, Jacques / Vial, Thierry et al. | 2008
- 499
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Current Practices in the Preclinical Safety Assessment of PeptidesHeidel, Shawn M. / Page, Todd J. et al. | 2008
- 517
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Enzyme Replacement TherapiesAndrews, Laura / O'Callaghan, Michael et al. | 2008
- 537
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Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the ToxicitiesLevin, Arthur A. / Henry, Scott P. et al. | 2008
- 575
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Preclinical Safety Evaluation of Biological Oncology DrugsReynolds, Theresa et al. | 2008
- 587
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Preclinical Safety Evaluation of Monoclonal AntibodiesTreacy, George / Martin, Pauline et al. | 2008
- 601
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Immunomodulatory Biopharmaceuticals and Risk of NeoplasiaBugelski, Peter J. / Sachs, Clifford / Cornacoff, Joel / Martin, Pauline / Treacy, George et al. | 2008
- 633
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Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold TherapeuticsRoberts, Stanley A. / Woodnutt, Gary / Bradshaw, Curt W. et al. | 2008
- 649
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Preclinical Safety Evaluation of ImmunotoxinsBrown, Jennifer G. / Entwistle, Joycelyn / Glover, Nick / MacDonald, Glen C. et al. | 2008
- 669
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Preclinical Safety Evaluation of Blood ProductsLewis, Richard M. et al. | 2008
- 683
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Preclinical Safety Evaluation of Viral VaccinesDempster, A. Marguerite / Haworth, Richard et al. | 2008
- 713
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Preclinical Safety Evaluation of BiopharmaceuticalsSerabian, Mercedes A. / Huang, Ying et al. | 2008
- 749
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Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell‐Based TherapiesCavagnaro, Joy A. et al. | 2008
- 783
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Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device)Babbitt, Bruce / Sall, Barry et al. | 2008
- 799
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Tissue Engineered Products: Preclinical Development of Neo‐OrgansBertram, Timothy A. / Jayo, Manuel et al. | 2008
- 827
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GLP Requirements and Current PracticesScharton‐Kersten, Tanya et al. | 2008
- 851
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Preclinical Safety Study Design Templates and Estimated CostsWolfe, Gary W. et al. | 2008
- 913
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Practical Considerations in the Design of Preclinical Safety Assessments for BiopharmaceuticalsDemady, Damon R. et al. | 2008
- 931
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Survey of Preclinical Toxicology Programs for Approved BiopharmaceuticalsO'Connor, Anita Marie et al. | 2008
- 969
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Science and Judgment in Establishing a Safe Starting Dose for First‐in‐Human Trials of BiopharmaceuticalsVisich, Jennifer / Ponce, Rafael et al. | 2008
- 985
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A RetrospectiveDayan, Anthony D. et al. | 2008
- 999
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Index| 2008
- c1
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Color Plates| 2008
- i
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Frontmatter| 2008