We can prepare comprehensive evaluations (position papers) for genotoxicity and carcinogenicity data available for your drugs. We have extensive knowledge of regulatory affairs and can recommend efficient testing strategies for safety assessment that optimally combine in silico approaches, in vitro and in vivo testing.
Our Regulatory Services
All of our studies can be carried out under Good Laboratory Practice (GLP).
- OECD 431 In vitro skin corrosion in 3D skin models
- OECD 432: 3T3 Neutral Red Uptake Phototoxicity Test
- OECD 439 In vitro skin irritation in 3D skin models
- OECD 471 Bacterial reverse mutation test (Ames test)
- OECD 473 In vitro mammalian chromosome aberration test (CAT)
- OECD 474 Mammalian erythrocyte micronucleus (MN) test
- OECD 475 Mammalian bone marrow chromosome aberration test
- OECD 476 In vitro mammalian cell gene mutation test (MLA) with mouse lymphoma cells (TK-locus)
- OECD 486 Unscheduled DNA synthesis (UDS) test in mammalian liver cells in vivo
- OECD 487 In vitro mammalian cell micronucleus (MN) test
Our advanced assays include
- Comet assay in vivo in various different target organs/ in vitro/ex vivo (human biomonitoring)
- Incorporation of genotoxicity endpoint in 28-d or 90-d repeated dose toxicity studies
- BlueScreen HC genotoxicity screening assay
- Screening versions of the regulatory genotoxicity assays
- In vitro screening assays, such as cytotoxicity or release of inflammatory mediators
- In vivo oral photosafety study in rodents
- In vivo dermal photosensitisation test in guinea pigs
- In vitro 3D skin phototoxicity test using human reconstructed skin models
As the in vitro assays currently available to assess photogenotoxicity are considered oversensitive, we therefore offer assays using alternative models, such as ex vivo human skin and in vivo rat skin. Such alternatives may allow exploration of the mechanisms of the photo-induced effect in addition to phototoxicity evaluation. In addition to our toxicology services, we offer analytical services to demonstrate exposure in both in vitro and in vivo studies.