國立高雄大學圖資館 |

Language: English

Back

Pharmacokinetics in drug development...

Bonate, Peter L.

Pharmacokinetics in drug development.Volume 4,Problems and challenges in oncology

Record Type:	Electronic resources : Monograph/item
Title/Author:	Pharmacokinetics in drug development.edited by Peter L. Bonate, Danny R. Howard.
remainder title:	Problems and challenges in oncology
other author:	Bonate, Peter L.
Published:	Cham :Springer International Publishing :2016.
Description:	xii, 330 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	Antineoplastic agentsDevelopment.
Online resource:	http://dx.doi.org/10.1007/978-3-319-39053-6
ISBN:	9783319390536$q(electronic bk.)

Pharmacokinetics in drug development.Volume 4,Problems and challenges in oncology
Pharmacokinetics in drug development.Volume 4,Problems and challenges in oncology[electronic resource] /Problems and challenges in oncologyedited by Peter L. Bonate, Danny R. Howard. - Cham :Springer International Publishing :2016. - xii, 330 p. :ill., digital ;24 cm.

Overview 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.

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.

ISBN: 9783319390536$q(electronic bk.)

Standard No.: 10.1007/978-3-319-39053-6doiSubjects--Topical Terms:

275191
Antineoplastic agents
--Development.

LC Class. No.: RS431.A64 / P43 2016

Dewey Class. No.: 616.994061

Pharmacokinetics in drug development.Volume 4,Problems and challenges in oncology
LDR:03025nmm a2200325 a 4500 001 498134
003 DE-He213
005 20161006171710.0
006 m d
007 cr nn 008maaau
008 170511s2016 gw s 0 eng d
020 $a 9783319390536$q(electronic bk.)
020 $a 9783319390512$q(paper)
024 7 $a 10.1007/978-3-319-39053-6 $2 doi
035 $a 978-3-319-39053-6
040 $a GP $c GP
041 0 $a eng
050 4 $a RS431.A64 $b P43 2016
072 7 $a TDCW $2 bicssc
072 7 $a MED072000 $2 bisacsh
082 0 4 $a 616.994061 $2 23
090 $a RS431.A64 $b P536 2016
245 0 0 $a Pharmacokinetics in drug development. $n Volume 4, $p Problems and challenges in oncology $h [electronic resource] / $c edited by Peter L. Bonate, Danny R. Howard.
246 3 0 $a Problems and challenges in oncology
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2016.
300 $a xii, 330 p. : $b ill., digital ; $c 24 cm.
505 0 $a Overview 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 $a Antineoplastic agents $x Development. $3 275191
650 0 $a Pharmacokinetics. $3 190329
650 0 $a Drug development. $3 190608
650 1 4 $a Biomedicine. $3 273648
650 2 4 $a Pharmaceutical Sciences/Technology. $3 338426
650 2 4 $a Oncology. $3 195181
650 2 4 $a Mathematical and Computational Biology. $3 514442
700 1 $a Bonate, Peter L. $3 511020
700 1 $a Howard, Danny R. $3 511021
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-39053-6
950 $a Biomedical and Life Sciences (Springer-11642)