Clinical Pharmacology: Current Topics and Case Studies
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are pr
- PDF / 7,707,752 Bytes
- 398 Pages / 439.43 x 683.15 pts Page_size
- 98 Downloads / 209 Views
Clinical Pharmacology: Current Topics and Case Studies Second Edition
Clinical Pharmacology: Current Topics and Case Studies
Markus Müller Editor
Clinical Pharmacology: Current Topics and Case Studies Second Edition
Editor Markus Müller Universitätsklinik für Klinische Pharmakologie Medizinische Universität Wien Wien Austria
ISBN 978-3-319-27345-7 ISBN 978-3-319-27347-1 DOI 10.1007/978-3-319-27347-1
(eBook)
Library of Congress Control Number: 2016935068 Springer Cham Heidelberg New York Dordrecht London © 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 Springer International Publishing AG Switzerland is part of Springer Science+Business Media (www. springer.com)
Contents
Part I
Introduction
1
The Discipline of Clinical Pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . 3 Markus Müller
2
Current Issues in Drug Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Markus Müller
3
Current Issues in Drug Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Christa Wirthumer-Hoche and Brigitte Bloechl-Daum
4
Current Topics in Drug Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . 33 Anna Bucsics, Robert Sauermann, and Valerie Nell-Duxneuner
Part II
Clinical Trials
5
Ethics in Clinical Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Ernst Singer and Christiane Druml
6
Good Clinical Practice (GCP) and Scientific Misconduct. . . . . . . . . . . 61 Brigitte Bloechl-Daum
7
Phase I Studies and First-In-Human Trials . . . . . . . . . . . . . . . . . . . . . . 85 Ulla Derhaschnig and Bernd Jilma
8
Clinical Trials: Interventional Studies . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Michael Wolzt and Stefan Aschauer
9
Observational Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Harald Herkner and Christoph Male
Part III
Tools in Clini
Data Loading...
