Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence

Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence Based on Cutaneous Pharmacokinetics

The specific aims of this research include comparing in vivo cutaneous pharmacokinetic (PK) measurements by independent techniques such as dermal open flow microperfusion (dOFM), dermal microdialysis (dMD), or spectroscopic tomography; exploring the removal of the topical formulations at different time points and characterizing the resulting PK profiles of the test product and the reference standard; developing data analysis techniques; and identifying appropriate PK endpoints for the evaluation of topical BE. The outcomes of this research are expected to help US Food and Drug Administration (US-FDA) improve the efficiency of current BE approaches for topical generic products with compositional differences relative to the reference standard.

Read more about Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence Based on Cutaneous Pharmacokinetics here

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD007669 totaling $1,500,000 funded by FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.


JOANNEUM RESEARCH HEALTH is seeking a limited number of clinical partners to adopt the Clinical Dermal Open Flow Microperfusion ( dOFM™) development approach. 

For the last decade, JOANNEUM RESEARCH HEALTH has been pioneering the use of our proprietary dermal Open Flow Microperfusion (dOFM™) technology to support the translational development of dermal drug products. By obtaining pharmacokinetics and pharmacodynamics data at or near the sites of action in skin, dOFM™ studies have been able to rapidly derisk/endorse drug development decisions. As we are seeking long-term, synergetic partnerships, we are open to innovative propositions to create a win-win arrangement with potential partners. Please forward your letter of interest (LOI) until December 31, 2022

For further inquiry and LOI submission, please visit our dedicated landingpage: Call for Partnership

RaDes GmbH collaborates with Joanneum Research HEALTH

RaDes GmbH collaborates with Joanneum Research HEALTH

Joanneum Research HEALTH and RaDes GmbH are committed to accelerate novel therapeutic options for dermatology patients. Confirming our shared vison at the Skin Forum in Malmö, we would like to announce a collaboration of the formulation expertise of RaDes and the dermal Open Flow Microperfusion (dOFM) PK/PD technique of Joanneum Research HEALTH to support rational development of dermatology drug products.

In addition to pharmacokinetic (PK) profiling, HEALTHs unique and powerful dOFM allows pharmacodynamic (PD) profiling. Biological effects of the drug product can be monitored through determination of biomarkers. This offers our clients further de-risking in their development projects before entering into clinical trials.


New Publication "Advanced Online Monitoring of In Vitro Human 3D Full-Thickness Skin Equivalents“

New Publication "Advanced Online Monitoring of In Vitro Human 3D Full-Thickness Skin Equivalents“

Our new publication "Advanced Online Monitoring of In Vitro Human 3D Full-Thickness Skin Equivalents" is online.

Skin equivalents and skin explants are widely used for dermal penetration studies in the pharmacological development of drugs. Environmental parameters, such as the incubation and culture conditions affect cellular responses and thus the relevance of the experimental outcome.

However, available systems such as the Franz diffusion chamber, only measure in the receiving culture medium, rather than assessing the actual conditions for cells in the tissue. We developed a sampling design that combines open flow microperfusion (OFM) sampling technology for continuous concentration measurements directly in the tissue with microfluidic biosensors for online monitoring of culture parameters. We tested our design with real-time measurements of oxygen, glucose, lactate, and pH in full-thickness skin equivalent and skin explants.

Furthermore, we compared dermal penetration for acyclovir, lidocaine, and diclofenac in skin equivalents and skin explants. We observed differences in oxygen, glucose, and drug concentrations in skin equivalents compared to the respective culture medium and to skin explants.

Read the full text here: Read more

Dermal Research Focus_Frank Sinner


Frank Sinner, Vice President Regulatory & Strategic Affairs at HEALTH - Institute of Biomedicine and Health Sciences, introduces OFM in a new video interview series, highlighting projects and services in the area of dermal research. Read more

Webinar: Cerebral Open Flow Microperfusion (cOFM) for in vivo Cerebral Fluid Sampling – Comparison of cOFM and Microdialysis

Dr. Joanna Hummer and Dr. Florie Le Prieult share insights into cOFM's use and utility in the broader neuroscience field and specifically for the development of drugs for neurodegenerative diseases. 

Key Topics:

  • How to perform in vivo sampling of cerebral fluid with intact blood brain barrier
  • Established and new fields of application for cOFM
  • Comparison of cOFM and MD when sampling a lipophillic drug
  • Pharmacokinetics of therapeutic antibodies investigated with cOFM and MD

Information Material:

Live Recording
Presentation Slides
Presentation with Speaker Notes
Q&A Report

Smart-4-Fabry - Innovation to improve the quality of life of Fabry disease patients

The European-funded project Smart-4-Fabry has been conceived to obtain a new nanoformulation of GLA enzyme using nanocapsules, that will improve the toleration and efficacy compared to the current enzyme replacement treatment with non-formulated GLA. The innovation aims to achieve a significant reduction of the actual high cost of Fabry disease treatment and an improvement in the quality of life of Fabry disease patients. Join the final project workshop on 03-FEB-2021. Details and more information about the project under

Follow Up: Webinar - Informed decisions in dermal drug development with dOFM

We are pleased to announce that we have prepared some useful content from our Webinar "Informed decisions in dermal drug development with dOFM". Please find below a collection of valuable insights, a comprehensive Q&A Catalogue and easy access to all relevant resources. Browse through a collection of questions raised by our listeners during the live webinar to see which topics are particularly relevant for our audience. Take a more detailed look at the slides and download the presentation including some additional notes from our dOFM experts.

Live Recording
Presentation Slides
Speaker Notes
Q&A Report

FDA published Video about OFM

The U.S. Food and Drug Administration recently published a video showing the potential of dermal open-flow microperfusion (dOFM) for generic drug development. FDA approval for most topical generic drugs requires a clinical endpoint study to compare the therapeutic effect with the original product. JOANNEUM RESEARCH HEALTH has developed a new method and strategy (dOFM) to apply for the approval of generic drugs without the need of a clinical endpoint study. Now, the FDA has released a short video illustrating the use of dOFM to evaluate bioequivalence for topical drugs.

Further information


Collecting antibodies and large molecule biomarkers in mouse interstitial brain fluid: MS vs cOFM

In the latest issue of the Journal MABS, Florie Le Prieult and colleagues from AbbVie Germany published latest results they observed after measuring concentrations of a monoclonal anitbody - trastuzumab - in the interstitial brain fluid (ISF) of awake and freely moving mice. The only currently available methods for extracting ISF, are Microdialysis (MD) and cerebral open flow microperfusion (cOFM). For the first time, both methods were compared at a technical and performance level for the collection of large molecules in rodents. They found 10-fold higher absolute concentrations in cOFM samples compared to MD. In vivo recovery revealed an increased extraction of trastuzumab at low flow rates and a 6-fold higher absolute concentration at steady state than initially calculated with the in vitro recovery. The authors conclude that the “standardization of these complex methods makes the unraveling of ISF concentrations attainable for various diseases and modalities, starting in this study with mAbs, but extending further in the future to RNA therapeutics, antibody-drug conjugates, and even cell therapies.” 

Read more

Contact Us


Please reach out and we will answer
your questions, react to your ideas and
deal with your requirements.

Stay in touch