Overview
Contains new chapters of how treatment can be applied for major disease areas
Provides a background to aid the understanding of drug effects and non-drug treatment strategies on key biochemical-hormonal defects of obesity and type 2 diabetes
Aids the selection of the most appropriate techniques for assessing insulin action, insulin secretion and body composition in humans?
Provides practical examples to assist usage/applications, explanation and study analysis
Perils and pitfalls are summarized for each technique
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Table of contents (20 chapters)
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Front Matter
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Review of Clinical Investigative Methods
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Front Matter
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Preclinical Drug Development and Transitioning to Clinical Studies
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Front Matter
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Keywords
About this book
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 methods to assess the pharmacokinetics and pharmacodynamics of new diabetes drugs, e.g. the euglycemic clamp technique, have become well-established in proof-of-mechanism studies. However, selection of the most appropriate techniques is by no means straightforward. Moreover, the application of such methods must conform to the regulatory requirements for new drugs.
This book discusses the need for new pharmacotherapies for diabetes, obesity and NAFLD and the molecular targets of drugs currently in development. Emerging technologies including functional imaging, circulating biomarkers and omics are considered together with practical and ethical issues pertaining to early phase clinical trials in subjects with cardiometabolic disorders.
Translational Research Methods in Diabetes, Obesity, and Non-Alcoholic Fatty Liver Disease is of interest to biomedical scientists, pharmacologists, academics involved in metabolic research and clinicians practicing in these specialties.
Editors and Affiliations
About the editors
Christian Weyer is a pharmaceutical executive with over 20 years of experience in the drug development focused on diabetes, obesity, and NAFLD/NASH. As head of R&D at Amylin Pharmaceuticals and Intercept Pharmaceutics, he has contributed to the development, regulatory approval and/or life cycle management of several first-in-class medicines in the areas of type 1 and type 2 diabetes, lipodystrophy, and progressive non-viral liver diseases, as well as to the mid and late-stage development of novel drug candidates for obesity and NASH. Dr Weyer previously served as President and Chief Development Officer at ProSciento and as visiting fellow with the National Institutes of Health, NIDDK, and has authored over 100 peer-reviewed publications in the field of endocrinology and metabolism.
Marcus Hompesch, Chief Executive Officer and Chairman of the Board, ProSciento is a recognized expert in the field of metabolic diseases, a licensed physician and entrepreneur. His experience in designing, performing and publishing clinical studies in metabolic diseases has been gained through over 20 years of work as clinician and clinical researcher. To date Dr Hompesch has authored more than 90 publications, has been editor and author of a textbook on translational research methods and is editor-in-chief of the journal ‘Endocrinology, Diabetes & Metabolism’. He established ProSciento, Inc., CA in 2003
Bibliographic Information
Book Title: Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease
Book Subtitle: A Focus on Early Phase Clinical Drug Development
Editors: Andrew J. Krentz, Christian Weyer, Marcus Hompesch
DOI: https://doi.org/10.1007/978-3-030-11748-1
Publisher: Springer Cham
eBook Packages: Medicine, Medicine (R0)
Copyright Information: Springer Nature Switzerland AG 2019
Hardcover ISBN: 978-3-030-11747-4Published: 12 April 2019
eBook ISBN: 978-3-030-11748-1Published: 02 April 2019
Edition Number: 2
Number of Pages: XI, 556
Number of Illustrations: 56 b/w illustrations, 59 illustrations in colour
Topics: Diabetes, Metabolic Diseases, Pharmacology/Toxicology