Pharmacological testing of subcutaneous drugs

Injection into the subcutaneous fatty tissue is an important route of administration for many substances such as insulin or antibodies. The formation of drug depots in adipose tissue and drug distribution are crucial for assessing absorption into the blood, pharmaceutical effects or possible side effects. aOFM studies provide data on substance distribution in adipose tissue and pharmacodynamic effects in the target tissue.

Preclinical studies

Ex vivo experiments are carried out with freshly removed human and animal tissues. Our studies include animal models in awake and anaesthetized animals (rodents, pigs).

Clinical studies

Clinical trials range from first-in-human studies to phase 0 or phase 1 clinical trials in which subcutaneously administered drugs can be monitored for up to 36 hours using aOFM or microdialysis. Clinical trials can be conducted in healthy volunteers or in patients (diabetes type 1 and 2, acne, psoriasis...). Drug concentrations and PD markers are analyzed in our GLP-certified laboratory.

Multiple samples per application site allow for an efficient study design that provides a large amount of reliable data, while only a relatively small number of subjects are used in PK/PD studies.

Clinical trials are conducted according to ICH-GCP standards at the Clinical Trials Unit of the Medical University of Graz.

Additional expertise

• Combination of microdialysis and OFM technologies for protein binding studies.
• Testing and optimization of injection devices: Use of live in vivo imaging techniques (e.g. µCT) to visualize an injected substance depot directly in the tissue.
• Various glucose clamping techniques (hypo-, hyper-, eugylcemia) to determine the glucose infusion rate, insulin initiation time,...
• Studies with isotope-labeled insulins for monitoring glucose metabolism (endogenous glucose production and peripheral glucose uptake)