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HEALTH

GLP analysis of isotope-labeled glucose in blood 

Quality-assured determination of endogenous glucose production rates to study the effects of diabetes medications

Background

The treatment of diabetes using drugs has the primary aim to adjust glucose levels to the normal range. Diabetes medications (e.g., insulin, oral antidiabetic agents) influence not only the uptake of glucose from the blood into various tissues (e.g., muscle, liver), but also inhibit the body's glucose production. When diabetes medication is tested, it is essential to assess endogenous glucose production rates.

It is possible to determine endogenous production rates of glucose by using a controlled infusion of stable isotope-labeled glucose solutions and determination of the concentrations of this glucose in blood. Highly accurate and robust analytical methods based on mass spectrometry and complex mathematical methods are needed for this task.

In the course of the project, processes are developed that ensure the quality controlled determination of isotope-labeled glucose in blood using mass spectrometry.

The goal is to create robust, high-throughput methods that can also yield GLP-certified data for registration trials in cooperation with the Medical University of Graz.

Project Goals

  • Automation of high-throughput methods to measure glucose and isotope-labeled glucose (absolute quantification and trace to tracee ratio) in human plasma
  • Validation according to the highest quality standards (FDA Guidance for Industry, Bioanalytical Method Validation) and
  • Conducting test measurements according to GLP guidelines

 

Results

Automation of the method according to GLP guidelines has been implemented. The first order placed by an international sponsor has been successfully processed.

Automated, robotic system for high-throughput analysis
Automated, robotic system for high-throughput analysis
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