Services

Peptide Hormone Analysis

We analyse and differentiate endogenous or therapeutic peptides and interfering products in (pre-)clinical study samples.

reagenzglas

Selective and sensitive analysis of peptide hormones in clinical studies is challenging. Endogenous therapeutic peptides with a similar molecular structure, biological precursors, or inactive degradation products can interfere with the analytical method. This can lead to biased results and an erroneous biological interpretation of the study outcome. We provide an analytical solution for this challenge.

Our Services

  • Validated (EMA) method for the selective determination of human insulin and insulin analogues
  • Established selective glucagon assay
  • Method development for peptide hormones and therapeutic peptides based on ELISA or mass spectrometry
  • Method validation according to recent guidelines (EMA, FDA)
  • GLP or non-GLP analysis of study samples

Services

We analyze low volume samples from all biological matrices to determine PK/PD profiles and to support your biomarker research.

Fast and efficient PK based bioequivalence testing of topical generics.

We offer a wide range of specialized biostatistical services to manage all aspects of your study from design to data analysis.

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