Pharmacokinetics in Drug Development Problems and Challenges in Onco
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 bo
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macokinetics in Drug Development Problems and Challenges in Oncology, Volume 4
Pharmacokinetics in Drug Development
Peter L. Bonate • Danny R. Howard Editors
Pharmacokinetics in Drug Development Problems and Challenges in Oncology, Volume 4
Editors Peter L. Bonate Pharmacokinetics/Modeling/Simulation 2N.184 Astellas Global Clinical Pharmacology and Exploratory Development Northbrook, IL, USA
Danny R. Howard Oncology Clinical Pharmacology Novartis East Hanover, NJ, USA
ISBN 978-3-319-39051-2 ISBN 978-3-319-39053-6 DOI 10.1007/978-3-319-39053-6
(eBook)
Library of Congress Control Number: 2004051818 © Springer International Publishing Switzerland 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland
Contents
1
Overview of Oncology Drug Development ........................................... Laeeq Malik and Steven Weitman
1
2
Overview of Oncology Biomarkers ....................................................... Mitsukuni Suenaga, Heinz-Josef Lenz, and Stefan J. Scherer
29
3
A Global Perspective on First-in-Man Dose Selection: Oncology and Beyond ............................................................................. Peng Zou, Sau Lee, Min Li, Lawrence Yu, and Duxin Sun
39
4
Controversies in Oncology: Size Based vs. Fixed Dosing .................... Peter L. Bonate
59
5
Clinical QTc Assessment in Oncology ................................................... Margaret R. Britto and Nenad Sarapa
77
6
Expediting Drug Development: Breakthrough Therapy Designation .............................................................................................. 107 Carmen Ladner
7
Pharmacokinetics and Pharmacodynamics of Tyrosine Kinase Inhibitors................................................................. 121 Ana Ruiz-Garcia and Kenji Yamazaki
8
Combination Development.............................
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