Pharmacokinetics in drug development. Volume 4, Problems and challenges in oncology / Peter L. Bonate, Danny R. Howard, editors.
Bonate, Peter L., editor.; Howard, Danny, editor.
2016
RS431.A64 P43 2016eb
Available Online

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Title Pharmacokinetics in drug development. Volume 4, Problems and challenges in oncology / Peter L. Bonate, Danny R. Howard, editors.
ISBN 9783319390536 (electronic book)
3319390538 (electronic book)
9783319390512
3319390511
Published Switzerland : Springer, [2016]
Language English
Description 1 online resource.
Call Number RS431.A64 P43 2016eb
Dewey Decimal Classification 616.994061
Summary 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.
Note Includes index.
Access Note Access limited to authorized users.
Source of Description Description based on online resource; title from digital title page (viewed on Nov. 16, 2016).
Added Author Bonate, Peter L., editor.
Howard, Danny, editor.
Available in Other Form Pharmacokinetics in Drug Development.
Linked Resources Online Access
Record Appears in Online Resources > Ebooks
All Resources
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 .

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