MediTox s.r.o.


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 cells

In vivo test system: rodents (mouse, rat, hamster, guinea pig), non-rodents (rabbit, ferret, cat, dog, non-human primates, pig/mini pig)

Facilities available: conventional and SPF housing, BSL II, Tissue culture laboratory, Laboratory of clinical pathology, Laboratory of pahtology and histopathology

Administration routes: besides of common administration routes (oral and parenteral, topical), intra-cardial, intra-articular, intra-ocular, intra-nasal and implantation (sub-cutis, muscle and bone) 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)

Genetic Toxicology
Gene mutation in bacteria OECD 471, ICH S2(R1)
Mammalian chromosome aberration test in vitro OECD 473, ICH S2(R1)
Erythrocyte micronucleus test in vitro OECD 479, ICH S2(R1)
Erythrocyte micronucleus test in vivo, rodents OECD 474, ICH S2(R1)
Cytotoxicity in vitro ISO 10993-5
Mouse Lymphoma Assay (under preparation) OECD 490, ICH S2(R1)

General toxicology, safety, efficacy
MTD, DRF studies, rodents, non-rodents Non-GLP/GLP
Proof-of-concept studies, rodents, non-rodents Non-GLP/GLP
Acute (Single dose) toxicity, rodents, non-rodents Non-GLP/GLP
OECD 420, 423, 425, 402, EMA/ICH/VICH
Sub-acute, sub-chronic, chronic toxicity studies, rodents, non-rodents EMA/ICH/VICH, OECD 407, 408, 409, 410, 411, 452
Impurity qualification, rodents ICH Q3A (R2), ICH Q3B (R2)
Non-clinical development of fixed combination of medicinal products EMEA/CHMP/SWP/258498/2005
Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, rodents, non-rodents CPMP/ICH/286/95, ICH M3(R2)
Preclinical safety evaluation of biotechnology-derived products, rodents, non-rodents CPMP/ICH/302/95, EMA/CHMP/ICH/731268/1998, ICH S6(R1)
Preclinical pharmacological and toxicological testing of vaccines, rodents, non-rodents CPMP/SWP/465/95, CVMP/IWP/52/97
Nonclinical evaluation for anticancer pharmaceuticals, rodents, non-rodents CHMP/ICH/646107/2008, ICH S9
Immunotoxicity/Immunogenicity studies, rodents, non-rodents CHMP/ICH/167235/04
Antiviral efficacy (AVE), rodents, ferret Non-GLP/GLP
Antiglaucoma efficacy, dog Non-GLP/GLP

Safety pharmacology
ICH S7
Safety Pharmacology: CVS (ECG parameters, dog) ICH S7
Nonclinical evaluation of the potential for delayed ventricular repolarization, non-rodents CPMP/ICH/423/02, CPMP/ICH/539/00, ICH S7A, ICH S7B

Local effects
OECD 431
Eye irritation in vitro (ICE) OECD 438
Skin irritation in vivo, rabbit OECD 404
Eye irritation in vivo, rabbit OECD 405
Non-clinical local tolerance testing of medicinal products (dermal, ocular, vaginal, mucosal), rodents, non-rodents CPMP/SWP/2145/00, ISO 10993
Local tolerance after implantation, rodents, non-rodents ISO 10993-6

Medical device biocompatibility
ISO 10993-1
Animal welfare requirements ISO 10993-2
Tests for in vitro cytotoxicity ISO 10993-5, USP ˂88˃
Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3, USP ˂88˃
Tests for local effects after implantation ISO 10993-6, ˂88˃
Tests for irritation and skin sensitization ISO10993-10, ˂88˃
Tests for systemic toxicity ISO 0993-11, ˂88˃
Sample preparation and reference materials ISO 0993-12

Veterinary drugs and feed assessment
EFSA
Target animal safety studies, dog, cat, rabbit, rodents VICH GL43, 44, EFSA
Feed safety studies, rodents, non-rodents VICH/EFSA
Dental hygiene efficacy studies, dog VOHC
Bioequivivalence studies, rodents, non-rodents VICH
Immersion/Wash-out studies of spot-on preparation, dog EMA guidelines VICH (1998A), VICH (1998B) and EMA guideline (2012).

TK/PK/BE/Biodistribtion
CPMP/ICH/384/95, 3BS11A, OECD 417
Biodistribution studies, rodents, non-rodents, LCMS, HPLC, qPCR OECD 417, CPMP/ICH/385/95, 3BS11A

Disease models
Chronic glaucoma, dog
Acute contact dermatitis, pig
Arthritis model (ACLT, CCLT) dog
Diabetes type II, NHP
Influenza model, ferret