PK/PD Studies

General Study Portfolio

We can conduct a wide variety of studies:

  • Clinical in vivo testing
  • Preclinical in vivo studies
  • Preclinical ex vivo studies using human skin explant models
  • In vitro evaluations / validations / verifications
  • In vivo / ex vivo / clinical / preclinical

Clinical in vivo testing

Clinical PK/PD/BE studies can be included as part of broader dermatological and endocrinological studies. The OFM probes used are minimally invasive (0.36 mm in diameter) and allow repeated or prolonged sampling in patients or volunteers without leading to scarring or pigment changes. As a result, the study designs for the assessment of PK/PD and bioavailability can be streamlined. Meaningful data can be collected while simultaneously keeping the number of test subjects low.

Clinical trials are conducted in accordance with ICH-GCP standards at the Clinical Research Center at the Medical University of Graz.

Areas of application: skin, subcutaneous adipose tissue

Preclinical in vivo studies

During preclinical in vivo studies, we perform metabolic tests to measure the pharmacokinetics of active pharmaceutical substances (API). We examine how these are absorbed, metabolized and excreted by the body when administered via a transdermal, intravenous, intraperitoneal, or other route. Studies can be performed on either anesthetized or non-anesthetized animals over a period of up to 12 hours.

Our preclinical studies are conducted in cooperation with the Institute for Biomedical Research at the Medical University of Graz.

Animal models: pig / minipig, rat, mouse

Areas of application: skin, adipose tissue, brain

Preclinical ex vivo studies using human skin explants

Explanted pieces of skin are donated by patients undergoing plastic surgery (abdomen, chest). After appropriate preparation and cultivation of samples, we can perform ex vivo experiments under controlled conditions. This allows us to investigate the absorption and release of topically applied agents. The explanted skin samples are stored in and maintained by Biobank Graz at the Medical University of Graz.

Areas of application: skin

In-vitro Evaluation / Validation / Verification

In vitro testing is conducted prior to each in vivo or ex vivo study, and particularly to ensure the reliability of quantitative sampling.

First, we investigate the chemical stability of substances in the sample matrix, additionally conducting freeze-thaw cycle stability testing. Then, we examine the adsorption characteristics of the substances throughout the entire sampling system. This means that we verify whether the substances move from the OFM probe to the sample holder without significant adsorption on surfaces, when the planned perfusate and test solutions are used. The collected data helps us avoid subsequent misinterpretation of in-vivo and ex-vivo results.