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.

Local Effects (Irritation/Sensitization)
Skin Irritation/Corrosion in vitro OECD TG 431, 439
Skin Irritation in vivo OECD TG 405, ISO 10993-10
Eye Irritation/Corrosion in vitro OECD TG 437, 438
Eye Irritation/Corrosion in vivo OECD TG 404, ISO 10993-10
Skin sensitization in vivo (LLNA) OECD TG 429, ISO 10993-10

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

Genetic Toxicology
Bacterial Reverse Mutation Test, plate incorporation, micro fluctuation methods OECD TG 471, ICH S2(R1), ISO 10993-3
Mammalian Chromosome Aberration Test in vitro OECD TG 473, ICH S2(R1), ISO 10993-3
Mammalian Cell Micronucleus Test in vitro OECD TG 487, ICH S2(R1), ISO 10993-3
Mammalian Cell Gene Mutation Test in vitro OECD TG 476, 490, ICH S2(R1), ISO 10993-3
Mammalian Comet Assay in vivo OECD TG 489 ICH S2(R1), ISO 10993-3

* 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 (non-rodents)* OECD TG 414, ICH S5(R2)
Reproduction toxicity (non-rodents)* OECD TG 421, ICH S5(R2)
One-generation reproduction toxicity study (non-rodents)* OECD TG 415, ICH S5(R2)
Two-generation reproduction toxicity study (non-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
Human influenza model (ferrets)
Antiviral vaccines safety models (guinea pigs, hamsters, rabbits)
Chronic glaucoma model (dogs)
Osteoarthrosis model (rabbits, dogs)
Experimental myocardial infraction (dogs, pigs)
Liver ischemia-reperfusion injury model (dogs)
Contact dermatitis model (pig)
Dental and bone implantation (dogs, pigs)