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Pharmacokinetics in Drug Development

Problems and Challenges in Oncology, Volume 4

  • Peter L. Bonate
  • Danny R. Howard

Table of contents

  1. Front Matter
    Pages i-xii
  2. Laeeq Malik, Steven Weitman
    Pages 1-27
  3. Mitsukuni Suenaga, Heinz-Josef Lenz, Stefan J. Scherer
    Pages 29-37
  4. Peng Zou, Sau Lee, Min Li, Lawrence Yu, Duxin Sun
    Pages 39-58
  5. Margaret R. Britto, Nenad Sarapa
    Pages 77-106
  6. Ana Ruiz-Garcia, Shinji Yamazaki
    Pages 121-150
  7. Annie St-Pierre, Maribel Reyes, Vincent Duval
    Pages 151-174
  8. Antonio da Silva, Didier Renard
    Pages 175-188
  9. Nicolas André, Joseph Ciccolini, Marie Amélie Heng, Eddy Pasquier
    Pages 189-207
  10. Dean C. Bottino, Arijit Chakravarty
    Pages 209-235
  11. Liang Zhao, Li Hongshan, Anshu Marathe, Jingyu (Jerry) Yu, Dinko Rekić, Nitin Mehrotra et al.
    Pages 303-317
  12. Back Matter
    Pages 319-330

About this book

Introduction

 

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.

 

 

 

 

Keywords

TQT studies modeling tumor oncology drug dosage therapeutics

Editors and affiliations

  • Peter L. Bonate
    • 1
  • Danny R. Howard
    • 2
  1. 1.Pharmacokinetics/Modeling/Simulation 2N.184 AstellasGlobal Clinical Pharmacology and Exploratory DevelopmentNorthbrookUSA
  2. 2.Oncology Clinical Pharmacology NovartisEast HanoverUSA

Bibliographic information

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