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020 _a9783319390536
040 _aES-MaUEC
050 4 _aRS431.A64
_bP43 2016 EB
082 0 4 _a615.19
245 1 0 _aPharmacokinetics in Drug Development :
_bProblems and Challenges in Oncology, Volume 4
_cedited by Peter L Bonate, Danny R Howard
264 1 _aCham
_bSpringer International Publishing
_c2016
300 _a1 recurso en línea (XII, 330 páginas)
_b32 ilustraciones, 23 ilustraciones en color
336 _aTexto (visual)
_btxt
_2rdacontent
337 _aelectrónico
_bc
_2rdamedia
338 _arecurso electrónico
_bcr
_2rdacarrier
505 0 _aOverview of Oncology Drug Development -- A Global Perspective on First-In-Man Dose Selection: Oncology and Beyond -- Controversies in Oncology: Size-Based vs. Fixed Dosing -- Clinical QTc Assessment in Oncology -- Expediting Drug Development: Breakthrough Therapy Designation -- Pharmacokinetics and Pharmacodynamics of Tyrosine Kinase Inhibitors -- Combination Development -- Role of Pharmacokinetics-Pharmacodynamics in Biosimilar Assessments -- Pharmacokinetics and Pharmacogenetics of Metronomics -- Modeling Tumor Growth in Animals and Humans: an Evolutionary Approach -- Practical Considerations for Clinical Pharmacology in Oncology Drug Development: A Survey of Approvals from 2009-2015 -- New Advancements in Exposure-Response Analysis to Inform Regulatory Decision-Making .
520 _aBack cover copy In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely � to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamicconcepts for tyrosine kinases,the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist�s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented. .
650 7 _aOncología
_2embne
_9139207
700 1 _aBonate, Peter L.
_eeditor literario
_984103
_0Local
_0http://id.loc.gov/authorities/names/n00002391
_1http://viaf.org/viaf/20911002
700 1 _aHoward, Danny R.
_eeditor literario
_999554
_0Local
_1http://viaf.org/viaf/38209770
710 2 _aSpringerLink (Online service)
_0Local
_0http://id.loc.gov/authorities/names/no2005046756
_1http://viaf.org/viaf/148105729
_9106996
856 4 0 _uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-39053-6
_zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901 _ai9783319390536
907 _a.b1295388x
_b10-10-17
_c21-11-16
942 _2lcc
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988 0 0 _aEBOOK, EBSPRINGER, GOBI_sep2018
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