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…
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…
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…
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…
Fig. 6.1 Regulation of placental inflammatory response by dietary fatty acids. Saturated and monounsaturated fatty acids activate TLR4 leading to downstream inflammatory pathways JNK and NF-κB. JNK activates AP-1 transcription…
Fig. 3.1 Under eubiotic environment the intestinal endothelial cells secrete mucins and cytokines, which conditions dendritic cells to promote an antiinflammatory cellular and mediators to dampen effector responses Fig. 3.2…
