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In diabetic patient's, levels of the hepatocyte growth factor (HGF) were found in high levels, thus independently associated with increased the incidence of diabetes. There is a study that indicate that HGF/c-Met signalling is essential for maternal β-cell adaptation during pregnancy and that its absence/attenuation leads to gestational ...
Diabetes insipidus (DI) is a condition characterized by large amounts of dilute urine and increased thirst. [1] The amount of urine produced can be nearly 20 liters per day. [ 1 ] Reduction of fluid has little effect on the concentration of the urine. [ 1 ]
The FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers. [3] Surrogate endpoints can be obtained from different modalities, such as, behavioural or cognitive scores, or biomarkers from Electroencephalography , MRI, PET, or biochemical biomarkers.
Untreated central diabetes insipidus patients usually exhibit polyuria, nocturia, and polydipsia as a result of the initial rise of serum sodium and osmolality. [5] Patients may also experience neurologic symptoms associated with the underlying illness, such as headaches and diplopia, depending on the exact origin of the central diabetes insipidus.
A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
Both cause excessive urination (hence the similarity in name), but whereas diabetes insipidus is a problem with the production of antidiuretic hormone (neurogenic diabetes insipidus) or the kidneys' response to antidiuretic hormone (nephrogenic diabetes insipidus), diabetes mellitus causes polyuria via osmotic diuresis, due to the high blood ...
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.