Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease
This book aims to aid the selection of the most appropriate methods for use in early phase (1 and 2) clinical studies of new drugs for diabetes, obesity, non-alcoholic fatty liver disease (NAFLD) and related cardiometabolic disorders.Clinical research met
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Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease
Andrew J. Krentz Christian Weyer • Marcus Hompesch Editors
Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease A Focus on Early Phase Clinical Drug Development Second Edition
Editors Andrew J. Krentz ProSciento Chula Vista, CA USA
Christian Weyer ProSciento Chula Vista, CA USA
Marcus Hompesch ProSciento Chula Vista, CA USA
ISBN 978-3-030-11747-4 ISBN 978-3-030-11748-1 (eBook) https://doi.org/10.1007/978-3-030-11748-1 Library of Congress Control Number: 2019934762 © Springer Nature Switzerland AG 2019 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Foreword
Obesity, type 2 diabetes, and associated metabolic diseases such as nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH), have reached epidemic proportions on a global scale. Insulin resistance is a fundamental etiologic defect in type 2 diabetes, and obesity is the most common cause of insulin resistance in man. There is a great deal of phenotypic overlap between obesity, type 2 diabetes, and NAFLD/NASH, and the great majority of patients who ultimately develop NASH are obese and insulin resistant. Taken together, these disorders represent one of the greatest areas of unmet medical need, creating the opportunity to discover and test new potential drugs. The chapters in this book provide an important contribution to our knowledge on the scientific and regulatory issues related to preclinical studies, with a major emphasis on the early stages of clinical development. As such, the material in this book includes a discussion of the latest methodologies in metabolic research, fo
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