MediTox s.r.o.


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)


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)
Repeated dose 6 months oral carcinogenicity, OECD (transgenic mice)
Repeated dose 2 years oral carcinogenicity, OECD (rats)
Antiviral efficacy/Immunogenicity, EMA/ICH (rodents, non-rodents)
Antiglaucomic efficacy (non-rodents)
PK/TK(Biodistribution studies after single/repeated administration, non-labeled compounds, EMA/ICH (rodents, non-rodents)


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)


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