000 04297nam a22004695i 4500
001 978-1-4419-5955-3
003 DE-He213
005 20140220083232.0
007 cr nn 008mamaa
008 120423s2012 xxu| s |||| 0|eng d
020 _a9781441959553
_9978-1-4419-5955-3
024 7 _a10.1007/978-1-4419-5955-3
_2doi
050 4 _aRS1-441
072 7 _aMQP
_2bicssc
072 7 _aMED072000
_2bisacsh
082 0 4 _a615.1
_223
100 1 _aTabrizi, Mohammad A.
_eeditor.
245 1 0 _aDevelopment of Antibody-Based Therapeutics
_h[electronic resource] :
_bTranslational Considerations /
_cedited by Mohammad A. Tabrizi, Gadi G. Bornstein, Scott L. Klakamp.
264 1 _aNew York, NY :
_bSpringer New York,
_c2012.
300 _aXIV, 425p. 58 illus., 30 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aTranslational Strategies for Development of Antibody-Based Therapeutics: An Overview -- Discovery Process for Antibody-Based Therapeutics -- Technologies for the Generation of Human Antibodies -- Application of Antibody Engineering in the Development of Next Generation Antibody-Based Therapeutics -- Biophysical Considerations -- Considerations in Establishing Affinity Design Goals -- BioAnalytical Considerations: Pharmacokinetics and Immunogenicity -- Antibody-Based Therapeutics in Oncology : Preclinical Considerations -- Factors Impacting the Tumor Localization and Distribution -- Antibody-Based Therapeutics: Preclinical Safety Considerations -- Application of Pharmacokinetic/Pharmacodynamic Modeling -- Design of Translational Strategies : Application of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Approaches -- Translational Biomarkers: Essential Tools in Development of Antibody-Based Therapeutics -- Development of Antibody-Based Therapeutics: Translational Research in Alzheimer’s Disease -- Considerations in Manufacturing Process Development -- Next Generation Antibody-Based Therapeutics -- Immune Complex Therapies for Treatment of Immune Thrombocytopenia (ITP) -- Application of Bioinformatics Principles for Target Evaluation -- Concluding Remarks.
520 _aDevelopment of Antibody-Based Therapeutics: Translational Considerations examines important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics. Translational strategies for development of antibody-based therapeutics require an understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious biological effects from early stages of development. The flow of information across various stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates.  Successful strategies for the development of monoclonal antibodies require integration of knowledge with regards to target antigen properties in health and disease, as well as antibody design criteria including affinity, isotype selection, pharmacokinetics/pharmacodynamics (PK/PD) properties, antibody cross-reactivity across species, and safety. Selection and evaluation of appropriate biomarkers in early preclinical development in “relevant” animal models should allow identification of potential risks and liabilities of an antibody drug candidate to humans and establishment of safe First-In-Human (FIH) dosing strategies.  This volume provides a comprehensive review of the topics critical for establishing successful translational strategies for the development of antibody-based therapeutics.
650 0 _aPharmacy.
650 0 _aToxicology.
650 0 _aBiochemistry.
650 1 4 _aPharmacy.
650 2 4 _aPharmacy.
650 2 4 _aPharmacology/Toxicology.
650 2 4 _aBiochemistry, general.
700 1 _aBornstein, Gadi G.
_eeditor.
700 1 _aKlakamp, Scott L.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781441959539
856 4 0 _uhttp://dx.doi.org/10.1007/978-1-4419-5955-3
912 _aZDB-2-SME
999 _c100516
_d100516