EXPERIMENTAL SERVICES
Custom tailored program for non-clinical development, testing and support of CTA/MA to meet the needs of the clients and partners from pharma/biotech/medical device/food industry (EMA, ICH/VICH, FDA, ISO 10993/USP 88, EFSA)
Standard safety testing program to meet the needs of the clients and partners from chemical/agrochemical industry (ECHA, OECD TG - Section 4, US EPA)
In vitro test system: bacteria, mammalian cell cultures (2D/3D)
In vivo test system: rodents (mice, rats, hamsters, guinea pigs), non-rodents (rabbits, ferrets, cats, dogs, pigs/minipigs)
Facilities available:
Experimental housing: conventional and barrier housing, BSL II facility for small laboratory animals
Laboratory premises: fully equipped experimental surgery room, X-ray imaging, Laboratory of toxicology, Laboratory of clinical pathology, Laboratory of pathology and histopathology
Administration routes: besides of common administration routes (oral and parenteral, topical), intra-cardial, intra-articular, intra-ocular, intra-nasal, implantation (bone, muscle, subcutis) and inhalation routes are available.
Alternative methods of testing according to OECD, and/or ECVAM/ICVAM are strictly preferred whenever it is rational and justified.
Other services: consultancy in non-clinical toxicology, toxicopathology, quality assurance (revision of study documentation, consultany and implementing GLP)
HUMAN MEDICINE AREA
| Early preclinical development – ADME-Tox | ||
|---|---|---|
| LogP, solubility in water and DMSO | ||
| Solubility in FaSSIF, PAMPA permeability, Caco2 A→B permeability, fraction unbound in plasma, half-life, plasma, half-life in liver microsomes | ||
| Cytochrom P agonsts/antaghonists (CYP1A2, CYP2A9, CYP2C9, CYP2C10, CYP2D6, CYP3A4, CYP19A1, AhR activator, CAR agonist / inhibitor, PXR agonist, CSTO1 inhibitor, ALDH1A1 inhibitor | ||
| 2D/3D cytotoxicity, genotoxicity, hERG inhibitor | ||
| Preclinical development | |
|---|---|
| General toxicity | |
| Exploratory studies | MTD, DRF, Proof-Of-Concept, Pilot studies (rodents, non-rodents) |
| Regulatory studies | Single dose (acute) and repeated dose (subacute, subchronic, chronic), OED, EMA, ICH (rodents, non-rodents) |
| General toxicity | |
| In vitro | Ames, CHA, MNT, MLA, Comet assay, OECD, EMA, ICH |
| In vivo | MNT, Comet assay, OECD, EMA, ICH (rodents) |
| Cytotoxicity | 2D/3D |
| Local effects | |
| In vitro | Skin, eye irritation/corrosion, skin sensitization, OECD |
| In vivo | Skin, eye irritation, skin sensitization, OECD, EMA, ICH (rodents), local tolerance, EMA, ICH (rodents, non-rodernts) |
| Safety pharmacology | |
| CVS (hERG, ECG), CNS (FOB), respiratory (head-out plethysmography), EMA/ICH (rodents, non-rodents) | |
| Other non-clinical safety | |
| Nonclinical evaluation of the potential for delayed ventricular repolarization, EMA/ICH (non-rodents) | |
| Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, EMA/ICH, (rodents, non-rodents) | |
| Immunotoxicity/Immunogenicity studies, EMA/ICH (rodents, non-rodents) | |
| Preclinical safety evaluation of biotechnology-derived products, EMA/ICH (rodents, non-rodents) | |
| Preclinical pharmacological and toxicological testing of vaccines, EMA/ICH (rodents, non-rodents) | |
| Nonclinical evaluation for anticancer pharmaceuticals, EMA/ICH (rodents, non-rodents) | |
| Toxicity to reproduction | |
| Embryo-foetal Development, ICH (rats, rabbits) | |
| Prenatal developmental toxicity, ICH (rats, rabbits) | |
| Inhalation toxicity | |
| Acute inhalation toxicity (nose-only), OECD (rodents) | |
| Carcinogenicity | |
| Repeated dose 6 months oral carcinogenicity, OECD (transgenic mice) | |
| Repeated dose 2 years oral carcinogenicity, OECD (rats) | |
| Efficacy | |
| Antiviral efficacy/Immunogenicity, EMA/ICH (rodents, non-rodents) | |
| Antiglaucomic efficacy (non-rodents) | |
| PK/TK/Biodistribution | |
| PK/TK(Biodistribution studies after single/repeated administration, non-labeled compounds, EMA/ICH (rodents, non-rodents) | |
VETERINARY MEDICINE/ANIMAL FEED AREA
| Target animal safety, VICH (rabbits, dogs, cats) | |
| Bioavailability/Bioequivalence, VICH (rabbits, dogs, cats) | |
| Immersion/Wash-out study, EMA/VICH (dogs) | |
| Wipe test, EMA/VICH (dogs, cats) | |
| Feed testing | Palatability, feed safety studies, VICH, EFSA (rodents, non-rodents) |
MEDICAL DEVICE AREA
| Tests for genotoxicity, carcinogenicity, and reproductive toxicity, ISO 10993-3, OECD | |
| Tests for in vitro cytotoxicity, ISO 10993-5 | |
| Tests for local effects after implantation, ISO 10993-6 | |
| Tests for irritation and skin sensitization, ISO 10993-23 OECD | |
| Tests for systemic toxicity, ISO 10993-11, OECD |
