000			03682nam a22004935i 4500
001			978-3-319-39053-6
003			DE-He213
005			20180206183130.0
007			cr nn 008mamaa
008			161006s2016 gw | s |||| 0|eng d
020			_a9783319390536 _9978-3-319-39053-6
050		4	_aRS380
050		4	_aRS190-210
072		7	_aTDCW _2bicssc
072		7	_aMED072000 _2bisacsh
082	0	4	_a615.19 _223
245	1	0	_aPharmacokinetics in Drug Development _h[recurso electrónico] : _bProblems and Challenges in Oncology, Volume 4 / _cedited by Peter L. Bonate, Danny R. Howard.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2016.
300			_aXII, 330 p. 32 illus., 23 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		_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			_a Back 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		0	_aMedicine.
650		0	_aPharmaceutical technology.
650		0	_aOncology.
650		0	_aBiomathematics.
650	1	4	_aBiomedicine.
650	2	4	_aPharmaceutical Sciences/Technology.
650	2	4	_aOncology.
650	2	4	_aMathematical and Computational Biology.
700	1		_aBonate, Peter L. _eeditor.
700	1		_aHoward, Danny R. _eeditor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783319390512
856	4	0	_zLibro electrónico _uhttp://148.231.10.114:2048/login?url=http://dx.doi.org/10.1007/978-3-319-39053-6
912			_aZDB-2-SBL
942			_cLIBRO_ELEC
999			_c227719 _d227719