“Salus ante omnia”
“Salus ante omnia”
“Salus ante omnia”
OECD TG 428
VitroScreen’s expertise on OECD428 derives from almost 25 years conducting studies performed on human skin explants and 3D human reconstructed tissues in order to conduct prenetration study covering almost all the body barriers. We perform multisite studies applying advanced and sustainable analytical techniques such as HPLC-MS/MS and UPLC, avoiding the need for radiolabeled substances.Our skilled team has optimized the management and successful outcome for regulatory acceptance of these complex projects: thanks to this approach, VitroScreen is a recognized leader in performing non-animal studies for penetration, absorption, and bioequivalence. A further support is provided to customers by independent toxicology statement on penetration studies results.
OECD TG 428
VitroScreen’s expertise on OECD428 derives from almost 25 years conducting studies performed on human skin explants and 3D human reconstructed tissues in order to conduct prenetration study covering almost all the body barriers. We perform multisite studies applying advanced and sustainable analytical techniques such as HPLC-MS/MS and UPLC, avoiding the need for radiolabeled substances.Our skilled team has optimized the management and successful outcome for regulatory acceptance of these complex projects: thanks to this approach, VitroScreen is a recognized leader in performing non-animal studies for penetration, absorption, and bioequivalence. A further support is provided to customers by independent toxicology statement on penetration studies results.
Competitive Expertise
- Compliance to OECD TG 428: long experience in applying quality criteria and technical requirements outlined in the Guideline, guaranteeing robust and reliable data and positive regulatory outcome.
- Expertise on human body barriers: our expertise extends beyond ex vivo human skin explants to 3D tissue models, including skin, oral, vaginal, corneal, bladder, colonrectal, nasal, intestinal 3D Human reconstructed tissues.
- Medical device expertise: we cater specifically to the EU Regulation 2017/745 (MDR) requirements and Rule 21 for substance-based medical devices, offering tailored absorption protocols for intact and injured epithelia and mucosae.
Why MD industry is focusing in absorption and penetration studies
The new product classification criteria introduced by the Medical Device Regulation EU n. 2017/745 (MDR) for substance based medical devices (SBMDs) take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances or their metabolites occurs (Rule 21).
This means that epithelia and mucosae are recognized as targets of SBMDs and that absorption through body barriers becomes fundamental not only for safety assessment but also for SBMDs classification taking into account MD local distribution.
VitroScreen has developed specific protocols for absorption studies on intact and injured epithelia (both on ex vivo explants and reconstructed tissues). In absence of a specific Guideline on how to conduct and interpretate absorption and penetration study results for the MD field, the OECD TG 428 (principles, technical requirements acceptance criteria for study validation) is used as EU Validated Alternative and relevant guidance document.
- Bioequivalence testing: aligned with the 2016 FDA and 2018 EMA guidance, we perform in vitro permeation tests to demonstrate bioequivalence of dermatological products
- “Cold” Analytical Technique: VitroScreen has invested in an R&D project in order to validate alternative techniques to perform absorption and penetration studies without radiolabeled substances. This allows significant cost reduction, no addition of scintillation liquid to the samples (higher biological model integrity and higher sustainability), increased robustness, sensitivity, reproducibility, lower standard deviations and data dispersion.
Competitive Expertise
- Compliance to OECD TG 428: long experience in applying quality criteria and technical requirements outlined in the Guideline, guaranteeing robust and reliable data and positive regulatory outcome.
- Expertise on human body barriers: our expertise extends beyond ex vivo human skin explants to 3D tissue models, including skin, oral, vaginal, corneal, bladder, colonrectal, nasal, intestinal 3D Human reconstructed tissues.
- Medical device expertise: we cater specifically to the EU Regulation 2017/745 (MDR) requirements and Rule 21 for substance-based medical devices, offering tailored absorption protocols for intact and injured epithelia and mucosae.
Why MD industry is focusing in absorption and penetration studies
The new product classification criteria introduced by the Medical Device Regulation EU n. 2017/745 (MDR) for substance based medical devices (SBMDs) take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances or their metabolites occurs (Rule 21).
This means that epithelia and mucosae are recognized as targets of SBMDs and that absorption through body barriers becomes fundamental not only for safety assessment but also for SBMDs classification taking into account MD local distribution.
VitroScreen has developed specific protocols for absorption studies on intact and injured epithelia (both on ex vivo explants and reconstructed tissues). In absence of a specific Guideline on how to conduct and interpretate absorption and penetration study results for the MD field, the OECD TG 428 (principles, technical requirements acceptance criteria for study validation) is used as EU Validated Alternative and relevant guidance document.
- Bioequivalence testing: aligned with the 2016 FDA and 2018 EMA guidance, we perform in vitro permeation tests to demonstrate bioequivalence of dermatological products
- “Cold” Analytical Technique: VitroScreen has invested in an R&D project in order to validate alternative techniques to perform absorption and penetration studies without radiolabeled substances. This allows significant cost reduction, no addition of scintillation liquid to the samples (higher biological model integrity and higher sustainability), increased robustness, sensitivity, reproducibility, lower standard deviations and data dispersion.
Applicability Domains
- Chemicals: Environmental Health Criteria 235 – DERMAL ABSORPTION World Health Organization – 2006
- Cosmetics: SCCS/1358/10: Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients – 2010
- Transdermal Patches: EMA/CHMP/QWP/608924/2014: Guideline on quality of transdermal patches – 2014
- Biocides: ECHA Dermal absorption of PT 21 active substances – 2016
- Pesticides and Biocides: ENV/JM/MONO (2011) 36 – OECD Guidance notes on dermal absorption – 2011 (revision draft 2022)
- Pesticides: DG-Sanco/222/2000 rev. 7 – Guidance document on dermal absorption – 2004
- Pesticides: EFSA Journal 2017;15(6):4873 – Guidance on dermal absorption – 2017
- Bio-equivalence: EMA CHMP/QWP/708282/2018 – 2018
- Regulatory classification of Medical Devices according to Rule 21 of MDR 2017/745
- Drug Delivery and Controlled Release: R&D projects
- Metabolites toxicokinetic: on fully viable tissues
Applicability Domains
- Chemicals: Environmental Health Criteria 235 – DERMAL ABSORPTION World Health Organization – 2006
- Cosmetics: SCCS/1358/10: Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients – 2010
- Transdermal Patches: EMA/CHMP/QWP/608924/2014: Guideline on quality of transdermal patches – 2014
- Biocides: ECHA Dermal absorption of PT 21 active substances – 2016
- Pesticides and Biocides: ENV/JM/MONO (2011) 36 – OECD Guidance notes on dermal absorption – 2011 (revision draft 2022)
- Pesticides: DG-Sanco/222/2000 rev. 7 – Guidance document on dermal absorption – 2004
- Pesticides: EFSA Journal 2017;15(6):4873 – Guidance on dermal absorption – 2017
- Bio-equivalence: EMA CHMP/QWP/708282/2018 – 2018
- Regulatory classification of Medical Devices according to Rule 21 of MDR 2017/745
- Drug Delivery and Controlled Release: R&D projects
- Metabolites toxicokinetic: on fully viable tissues
