Analytical Services for pharmaceutical (topical), chemical, agrochemical, cosmetic compounds or substance based medical devices
In vitro dermal permeation tests (IVPT) are important to evaluate a potential risk of chemicals, of agrochemicals, of cosmetics, of pharmaceuticals in a topical drug delivery system, and to assess the skin absorption or skin penetration properties of a test compound. The in vitro permeation test has been shown to be an ideal bio-equivalence model, it is accepted by authorities in OECD TG428 and in MDR EU Regulation 2017(745) for medical devices.
In addition, the IVPT is in line with 3R (Replace, Refine, Reduce) and offers a considerable contribution to decrease in vivo studies with test animals.
The in vitro dermal permeation test (IVPT) allows also to assess the distribution of ingredients of substance based medical devices, a recent requirement by EU Regulation 2017(745), Appendix VIII, Rule 21 for risk class and safety assessment of substance-based medical devices, such as nasal/throat drops or sprays, syrups, vaginal creams or gels, skin creams for wounds, scars, skin diseases, oral agents to neutralize gastric acid, osmotic laxatives, etc. The IVPT allows the classification for substance-based medical devices in the human body in the classes Class IIa, IIb and III.
Also analytical services for the new ADME (absorption, distribution, metabolism, excretion) requirements of MDR 2017(745) are available.
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