Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease: A Focus on Early Phase Clinical Drug Development
Clinical research methods for assessing 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 will aid the understanding of the need for new pharmacotherapies for diabetes, obesity and nonalcoholic fatty liver disease and the molecular targets of drugs currently in development. Emerging technologies, including functional imaging, circulating biomarkers, tracer methodologies, and various omics-approaches are considered together with practical and ethical issues of early phase clinical trials.