Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

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Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

A Focus on Early Phase Clinical Drug Development

Editore

Springer

Anno

2019

Pagine

556

ISBN

9783030117474

I prezzi indicati possono subire variazioni poiché soggetti all'oscillazione dei cambi delle valute e/o agli aggiornamenti effettuati dagli Editori.

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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.

Quantification of Insulin Action in Human Subjects

Krentz, Andrew J. (et al.)

Pages 3-35
Assessment of Islet Alpha- and Beta-Cell Function

Madsbad, Sten (et al.)

Pages 37-74
Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins

Krentz, Andrew J. (et al.)

Pages 75-100
Measurement of Energy Expenditure

Westerterp, Klaas R.

Pages 101-119
Quantifying Appetite and Satiety

Gibbons, Catherine (et al.)

Pages 121-140

Non-invasive Quantitative Magnetic Resonance Imaging and Spectroscopic Biomarkers in Nonalcoholic Fatty Liver Disease and Other Cardiometabolic Diseases Associated with Ectopic Fat Deposition

Hamilton, Gavin (et al.)

Pages 141-160
Structural and Functional Imaging of Muscle, Heart, Endocrine Pancreas and Kidneys in Cardiometabolic Drug Development

Eriksson, Olof (et al.)

Pages 161-189
Positron Emission Tomography and Computed Tomography Measurement of Brown Fat Thermal Activation: Key Tool for Developing Novel Pharmacotherapeutics for Obesity and Diabetes

Buchsbaum, Monte S. (et al.)

Pages 191-210
Isotopic Tracers for the Measurement of Metabolic Flux Rates

Beysen, Carine (et al.)

Pages 211-243
Role of Tissue Biopsy in Drug Development for Nonalcoholic Fatty Liver Disease and Other Metabolic Disorders

Krentz, Andrew J. (et al.)

Pages 245-274
Utility of Invasive and Non-invasive Cardiovascular Research Methodologies in Drug Development for Diabetes, Obesity and NAFLD/NASH

Rodriguez-Araujo, Gerardo (et al.)

Pages 275-308
Omics: Potential Role in Early Phase Drug Development

Grallert, Harald (et al.)

Pages 309-347
Peptide Drug Design for Diabetes and Related Metabolic Diseases

Kaarsholm, Niels C.

Pages 351-368
Animal Models of Type 2 Diabetes, Obesity and Nonalcoholic Steatohepatitis – Clinical Translatability and Applicability in Preclinical Drug Development

Hansen, Henrik H. (et al.)

Pages 369-403
Drug Development for Diabetes Mellitus: Beyond Hemoglobin A1c

Bril, Fernando (et al.)

Pages 405-421
Emerging Circulating Biomarkers for The Diagnosis and Assessment of Treatment Responses in Patients with Hepatic Fat Accumulation, Nash and Liver Fibrosis

Iruarrizaga-Lejarreta, Marta (et al.)

Pages 423-448
Quantitative Approaches in Translational Cardiometabolic Research: An Overview

Maleki, Farzaneh (et al.)

Pages 449-466
Transitioning from Preclinical to Clinical Drug Development

Walford, Geoffrey A. (et al.)

Pages 467-486
Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders

Fleming, G. Alexander (et al.)

Pages 487-515
Early Phase Metabolic Research with Reference to Special Populations

Morrow, Linda A. (et al.)

Pages 517-538