Pharmacokinetics in Drug Development Problems and Challenges in Oncology, Volume 4

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...

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Bibliographic Details
Other Authors: Bonate, Peter L. (Editor), Howard, Danny R. (Editor)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2016, 2016
Edition:1st ed. 2016
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • 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