Translational Research Methods in Diabetes Obesity and Nonalcoholic Fatty Liver Disease A Focus on Early Phase Clinical Drug Development Andrew 3030117480 9783030117481

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Product details:

• ISBN 10: 3030117480
• ISBN 13: 9783030117481
• Author: Andrew J. Krentz

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.

Table of contents:

Part I. Review of Clinical Investigative Methods

1. Quantification of Insulin Action in Human Subjects

2. Assessment of Islet Alpha- and Beta-Cell Function

3. Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins

4. Measurement of Energy Expenditure

5. Quantifying Appetite and Satiety

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

7. Structural and Functional Imaging of Muscle, Heart, Endocrine Pancreas and Kidneys in Cardiometabolic Drug Development

8. Positron Emission Tomography and Computed Tomography Measurement of Brown Fat Thermal Activation: Key Tool for Developing Novel Pharmacotherapeutics for Obesity and Diabetes

9. Isotopic Tracers for the Measurement of Metabolic Flux Rates

10. Role of Tissue Biopsy in Drug Development for Nonalcoholic Fatty Liver Disease and Other Metabolic Disorders

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

12. Omics: Potential Role in Early Phase Drug Development

Part II. Preclinical Drug Development and Transitioning to Clinical Studies

13. Peptide Drug Design for Diabetes and Related Metabolic Diseases

14. Animal Models of Type 2 Diabetes, Obesity and Nonalcoholic Steatohepatitis – Clinical Translatability and Applicability in Preclinical Drug Development

15. Drug Development for Diabetes Mellitus: Beyond Hemoglobin A1c

16. Emerging Circulating Biomarkers for The Diagnosis and Assessment of Treatment Responses in Patients with Hepatic Fat Accumulation, Nash and Liver Fibrosis

17. Quantitative Approaches in Translational Cardiometabolic Research: An Overview

18. Transitioning from Preclinical to Clinical Drug Development

19. Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders

20. Early Phase Metabolic Research with Reference to Special Populations

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