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  Issue 1 (2006)

  Dermopharmacy News
Safety Test
Skin Models Gaining Ground

For years now it has been designated target in industrial nations to reduce the number of animal experiments for safety toxicological tests of industry chemicals, plant protective agents and medicaments. The objective could be achieved by using alternative methods based on biotechnologically established human skin models. The development of a method of the type for the testing of skin penetration nears completion.

The development of novel alternative methods was effected in the scope of an interdisciplinary joint project started in September 2002 and sponsored by funds of Bundesministerium für Bildung und Forschung (BMBF) (Federal Ministry for Education and Research). Dermatologists, pharmacologists, pharmacists and veterinarians from the following institutions were involved in the project:

  • Free University Berlin, Institute for Pharmacy
  • University of the Saarland, department Biopharmacy and Pharmaceutical Technology
  • Technical University Brunswick, Institute for Pharmaceutical Technology
  • Foundation Veterinarian University Hannover, Institute for Pharmacology, Toxicology and Pharmacy
  • Ludwig-Maximilians-University Munich, Clinic and Polyclinic for Dermatology and Allergology
  • Bundesinstitut für Risikobewertung (BfR) (Federal Institute for Risk Assessment), Berlin, ZEBET
  • Across Barriers GmbH, Saarbrücken
  • BASF AG, Ludwigshafen
  • Beiersdorf AG, Hamburg
  • Cognis Deutschland GmbH, Düsseldorf
  • Institut für Grenzflächen- und Bioverfahrenstechnik (Institute for Interface- and Bio-process Engineering), Fraunhofer, Stuttgart

After first of all test provisions were developed, optimized and compared in view of their reproducibility, in the end of last year, the one-year validation of the optimized test method was successfully terminated.

As the speaker of the project, professor Dr. Monika Schäfer-Korting of the Institut für Pharmazie (Institute for Pharmacy) at Free University Berlin explained, the results of this study will be furnished in brief to the Europäische Zentrum zur Validierung von Alternativmethoden (ECVAM) (European Center for the Validation of Alternative Methods) for an independent validation of alternative methods.

It is expected that the method can then be employed in the scope of the OECD-test guideline recently adopted for the determination of the uptake of foreign bodies.

Concomitant to the process development a training laboratory on bio-technologically reconstructed human skin models has been installed at the Institut für Pharmazie (Institute for Pharmacy) of Free University Berlin financed with EC funds. Since September 2005 scientists from industry and universities from all over Europe may become acquainted with alternative methods for animal experiments that are recognized and reached advanced developmental stages. Further information can be retrieved at the internet-address jk



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