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024 7 $a10.1007/978-3-319-39053-6
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035   $a(DE-He213)978-3-319-39053-6
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035   $z(PPN)258871113
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100   $a20161006d2016      u|         0
101 0 $aeng
135   $aurnn|008mamaa
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aPharmacokinetics in Drug Development $eProblems and Challenges in Oncology, Volume 4 /$fedited by Peter L. Bonate, Danny R. Howard
205   $a1st ed. 2016.
210  1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2016.
215   $a1 online resource (XII, 330 p. 32 illus., 23 illus. in color.) 
311   $a3-319-39051-1 
311   $a3-319-39053-8 
320   $aIncludes bibliographical references at the end of each chapters and index.
327   $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 .
330   $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. .
606   $aPharmaceutical technology
606   $aOncology
606   $aBiomathematics
606   $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010
606   $aOncology$3https://scigraph.springernature.com/ontologies/product-market-codes/H33160
606   $aMathematical and Computational Biology$3https://scigraph.springernature.com/ontologies/product-market-codes/M31000
615  0$aPharmaceutical technology.
615  0$aOncology.
615  0$aBiomathematics.
615 14$aPharmaceutical Sciences/Technology.
615 24$aOncology.
615 24$aMathematical and Computational Biology.
676   $a615.19
702   $aBonate$b Peter L$4edt$4http://id.loc.gov/vocabulary/relators/edt
702   $aHoward$b Danny R$4edt$4http://id.loc.gov/vocabulary/relators/edt
906   $aBOOK
912   $a9910253899303321
996   $aPharmacokinetics in Drug Development$92521350
997   $aUNINA