Endocrine Abstracts

Introduction: Rapid-acting insulins is widely used in the treatment of either type 1 diabetes mellitus, or type 2 diabetes mellitus. A mealtime injection of rapid-acting insulin, such as insulin aspart, allow the diabetic patients to control the levels of post-prandial glucose. The clinical development plan of the insulin biosimilarsusually contains pharmacology studies to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety of the investigational products...

IntroductionA biosimilar is a biological medicinal product that shows high similarity to another already approved medicine product containing biotechnology-derived protein as active substance. The similarity depends on the biosimilar development program that includes comparative studies of physical and chemical properties, in vitro pharmacodynamics, pharmacokinetics and pharmacodynamics in humans. Insulin aspart biphasic 30 is one of the most co...