MediTox s.r.o.


EXPERIMENTAL SERVICES

Complex preclinical and toxicological program for development and testing is custom tailored to meet the needs of our clients and partners in the pharmaceutical, biotechnology and chemical industry.

In vitro test system: mammalian cells, bacteria

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

General Toxicology

MediTox covers core battery of non-clinical safety tests and studies providing the substantial information on the drugs to support phases I - III of clinical trial and to keep requirements of REACH for safety assessment of chemicals and chemical preparations.

All routes of administration, all common laboratory species, conventional housing conditions and SPF units are available. The toxicologists have experience with variety of compounds and therapeutic areas. The substantial advantage is long experience in the work with dogs and non-human primates.

MediTox provides a comprehensive quality assurance program covering every aspect of the experimental work from initiation of the study to specimen handling, data management and reporting of results. MediTox also strongly streams to use alternative methods of testing according to OECD, and/or ECVAM whenever it is rational and justified.

Irritation/Sensitization
Skin Irritation/Corrosion in vivo OECD TG 404, ISO 10993-10
Skin Sensitization: Local Lymph Node Assay* OECD TG 429,
Skin sensitization in vivo OECD TG 406, ISO 10993-10
Eye Irritation/ Corrosion in vivo OECD TG 405, ISO 10993-10
In vitro skin irritation* OECD TG 439

Acute (Single Dose) Toxicity
Acute toxicity, rodents, OECD TG 420, 423, 425, 402, EMA
Maximum tolerated dose, rodents, non-rodents CHMP/SWP/302413/08
Extended single dose toxicity study, rodents ICH M3 (R2), EMA
Acute systemic toxicity, rodents ISO 10993-11

Repeated Dose Toxicity
Dose range finding (rodents, non-rodents) CPMP/SWP/1041/99, ICH S4
14-21 days repeated dose toxicity study (rodents, non-rodents) CPMP/SWP/1041/99, ICH S4, ISO 10993-11
28-day repeated dose toxicity study (rodents, non-rodents) CPMP/SWP/1041/99, OECD TG 407, TG 410,
ICH S4, ISO 10993-11
90-day repeated dose toxicity study (rodents, non-rodents) CPMP/SWP/1041/99, OECD TG 408,409,
ICH S4, ISO 10993-11
6-month repeated dose toxicity study (rodents, non-rodents) CPMP/SWP/1041/99, OECD TG 452, ICH S4
9 - 12 month repeated dose toxicity study(non-rodents) CPMP/SWP/1041/99, OECD TG 452, ICH S4

Genotoxicity/Mutagenicity
Gene Mutation in Bacteria* OECD TG 471, ICH S2(R1), ISO 10993-3
Mammalian Chromosome Aberration in vitro OECD TG 473, ICH S2(R1), ISO 10993-3
Erythrocyte Micronucleus in vivo OECD TG 474, ICH S2(R1), ISO 10993-3
Erythrocyte Micronucleus in vitro OECD TG 487, ICH S2(R1), ISO 10993-3
Cytotoxicity in vitro ISO 10993-5
Mouse lymphoma Assay* OECD 490

* Provided in the cooperation or subcontracted

Non-Clinical Safety & Pharmacology
Non-clinical safety studies (rodents, non-rodents) EMA, ICH
Non-clinical local tolerance testing of medicinal products (rodents, non-rodents) EMA, ICH
Non-clinical implantation studies ( rodents, non-rodents) EMA, ICH, ISO 10993-6
Immunotoxicity/Immunogenicity studies (rodents, non-rodents) EMA, ICH S8
Preclinical safety evaluation of biotechnology-derived products (rodents, non-rodents) EMEA/CHMP/945626/2005, ICH S6 (R1)
Safety pharmacology studies ICH S7A, S7B
Non-clinical evaluation for anticancer pharmaceuticals (rodents, non-rodents) ICH S9
Preclinical pharmacological and toxicological testing of vaccines (rodents, ferrets, non-human primates) CPMP/SWP/465/95, CVMP/IWP/52/97, CHMP/VWP/141697/2009,
Non-clinical evaluation of biological medicinal products (rodents, non-rodents) EMA/CHMP/BWP/247713/2012, EMEA/CHMP/BWP/49348/2005
EMA/CHMP/BMWP/403543/2010
EMEA/CHMP/BMWP/118264/2007
EMEA/CHMP/BMWP/32775/2005
EMEA/CHMP/BMWP/101695/2006
EMEA/CPMP/3097/02

Carcinogenicity & Reproduction
Dose selection for carcinogenicity studies of pharmaceuticals (rodents) ICH S1C(R2)
Carcinogenicity study (rodents) OECD TG 451, ICH S1A, B, C(R2)
Combined chronic toxicity/carcinogenicity study (rodents) OECD TG 453 (452+451), ICH S1A, B, C(R2)
Prenatal developmental toxicity (rodents)* OECD TG 414, ICH S5(R2)
Reproduction toxicity (rodents)* OECD TG 421, ICH S5(R2)
One-generation reproduction toxicity study (rodents)* OECD TG 415, ICH S5(R2)
Two-generation reproduction toxicity study (rodents)* OECD TG 416, ICH S5(R2)

* Provided in the cooperation or subcontracted

Biodistribution
Biodistribution studies in rodents/non-rodents after single/repeated administration, non-labeled compounds, biological part OECD TG 417, ICH S3A, B

Other Studies
Biocompatibility studies for evaluation of medical devices ISO 10993
Target animal safety studies (rodents, non-rodents) VICH GL 41, GL 43, GL44
Dose determination study in target animals (rodents, non-rodents) VICH GL 43
Palatability study (rodents, non-rodents)

Animal Models of Selected Human Diseases
Diabetes type II model (non-human primates)
Chronic glaucoma model (dogs)
Acute contact dermatitis model (pigs)
Arthritis model (rabbits, guinea pigs, dogs)
Liver ischemia/reperfusion injury model (dogs)
Experimental myocardial infarction model (dogs, pigs)
Balloon vascular injury model (non-human primates)

Physical-Chemical Properties & Ecotoxicology

Basic battery of physico-chemical tests and eco-toxicity studies for environmental risk assessment according to REACH is provided in collaboration with GLP-certified laboratory at VUOS a.s.