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) | |
