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Pharmacokinetics in Drug Development: Problems and Challenges in Oncology

Bonate, Peter L.

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Book Information
Edition:	1st
Publisher:	Springer Nature
ISBN:	3-319-39053-8 (3319390538)
ISBN-13:	978-3-319-39053-6 (9783319390536)
Binding:	E E Book + ProQuest Ebook Central
Copyright:	2016
Publish Date:	10/16
Volume:	4
Weight:	0.00 Lbs.
Subject Class:	PRM (Pharmacology)
Return Policy:	Non-Returnable.

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Class Specifications
Discipline:	Pharmacology
Subject Definition:	Pharmacokinetics; Drug Design
NLM Class:	QV 38
LC Class:	RM301.5
Abstract:	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-pharmacodynamic concepts 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.

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