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Glucose Clamping Studies

  • Regulatory agencies require pharmacodynamic data on time-action profiles for new or biosimilar insulin preparations, including pre-mixed insulins, using the glucose clamp procedure
  • In addition there is a general agreement among experts that the glucose clamp procedure is the best available method for the assessment of insulin action
  • Clamp experiments are designed to counteract the blood-glucose-lowering effect of drugs (e.g. insulin or oral antidiabetic agents) by delivering variable amounts of glucose, which maintain blood glucose concentrations at a predetermined target level
Solutions
  • Handling of both Healthy subject & Patient studies
  • Protocol Design and insights in clamp protocol
  • Clamp data analysis and interpretation
  • Execution of Glucose clamp at Clinical facility (Healthy subjects)
  • PK sample estimation using ELISA

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