Please note, this OEL/ADE monograph also applies to pramlintide acetate (CAS RN 187887-46-3). Pramlintide acetate is an amylin analog indicated for patient with type 1 or type 2 diabetes who use insulin at meals and have failed to achieve desired glycemic control despite optimal insulin therapy. Pramlintide is an analog of human amylin. Amylin is collocated with insulin in secretory granules and co-secreted with insulin by pancreatic beta cells in response to food intake. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals. In patients with type 1 and type 2 diabetes, there is reduced secretion from pancreatic beta cells of both insulin and amylin in response to food. Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms, as determined by nonclinical studies. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression Reproduction or unauthorized distribution is strictly prohibited. Use of this document must comply with the of endogenous glucose output from the liver. Amylin also regulates food intake through centrally mediated modulation of appetite.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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