Measurement of Energy Expenditure

Oct 16, 2016 by in ENDOCRINOLOGY Comments Off on Measurement of Energy Expenditure

Method Measurement Advantages Disadvantages Value in drug development decisions Mouthpieceor facemask O2 consumption and CO2 production from breathing Minimal response time; no dilution of respiratory gases Mouthpiece and facemask are…

read more

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

Oct 16, 2016 by in ENDOCRINOLOGY Comments Off on Positron-Emission Tomography and Computed Tomography Measurement of Brown Fat Thermal Activation: Key Tools for Developing Novel Pharmacotherapeutics for Obesity and Diabetes

Method Measurement Advantages Disadvantages Value in drug development decisions Thorax computed tomography (CT) Yields Hounsfield unit images which can be segmented into types of fat, muscle, air, and bone; tissue…

read more

Assessment of β-Cell Function

Oct 16, 2016 by in ENDOCRINOLOGY Comments Off on Assessment of β-Cell Function

  Method Measurement Advantages Disadvantages Value in drug development decisions Fasting serum insulin and/or C-peptidea Serum insulin and/or C-peptide measured after an overnight fast Fasting insulin; homeostasis model assessment (HOMA-B)…

read more

Omics: Potential Role in Early-Phase Drug Development

Oct 16, 2016 by in ENDOCRINOLOGY Comments Off on Omics: Potential Role in Early-Phase Drug Development

  Methodology/platforms Measurement Advantages Disadvantages Value in drugdevelopment decisions Single locus (<100) determination PCR-based assays on different platforms PCR products depending on allele by fluorescence, gel electrophoresis, or matrix-assisted laser…

read more

Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders

Oct 16, 2016 by in ENDOCRINOLOGY Comments Off on Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders

Fig. 12.1 The major components of the Common Technical Document (CTD) Recent History in the FDA Review Divisions More recent history of the FDA reviews involved in cardiometabolic therapeutic regulation…

read more
Get Clinical Tree app for offline access