Method Measurement Advantages Disadvantages Value in drug development decisions Fasting hepatic DNL 2–3 days of oral administration of deuterated water (2H2O) The fraction of palmitate that is newly synthesized…
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)…
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…
1. Disease status (a) How was the diagnosis made? (b) Consideration of variant forms of diabetes (e.g. pancreatic insufficiency secondary to pancreatic disease, MODY, etc.) (c) Duration of disease i….
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…
Fig. 4.1 Normal distribution of inflammatory cells at the feto-maternal interface. Decidual natural killer and macrophages accumulate near the maternal spiral artery during the remodeling process. The vessel undergoes dramatic…
Fig. 10.1 Metabolic constraint on gestation length and fetal size. (Y axis). Fetal energy demands (green line, kcal/day) increase exponentially during gestation (X axis). Maternal energy expenditure (red line) rises…
Proinflammatory Anti-inflammatory Omega-6 fatty acids Omega-3 fatty acids Saturated fatty acids Polyphenols Excess carbohydrates The body requires a balance of these proinflammatory and anti-inflammatory nutrients in the diet to maintain…
Direct toxic substances Bacterial and fungal toxins Meal leftovers or “fast food” Coffee Excess Glutamate Chinese food Polycyclic aromatic hydrocarbon Grilled meat and vegetables Heavy metals Big fish, lead-covered pipes,…
Fig. 13.1 Mechanisms for the intergenerational transmission of programming effects. (a) Persistence of an adverse external environment can result in the reproduction of the phenotype in multiple generations. (b) The…
