ODBORNÁ EXPERIMENTÁLNÍ ČINNOST
Odborná činnost MediTox s.r.o. pokrývá šíři požadavků na preklinické studie bezpečnosti poskytující základní informace o vlastnostech léčiv, případně chemických látek, nutných pro jejich další vývoj a testování v průběhu klinických fází zkoušení a požadovaných registračními autoritami v procesu registrace (REACH).
Pro experimenty využíváme všechny běžné druhy laboratorních zvířat a experimentálních podmínek (konvenční, bariérové ustájení). Naší velkou výhodou jsou dlouholeté zkušenosti v práci s laboratorními psy a primáty.
MediTox s.r.o. uplatňuje komplexní program zabezpečení kvality pokrývající všechny činnosti od prvního kontaktu se zadavatelem, přes organizaci experimentů a získávání dat a zpracování výsledků až po archivaci veškeré dokumentace.
MediTox s.r.o. rovněž upřednostňuje využití alternativních metod testování (OECD, EU, ECVAM) všude tam kde je jejich užití smysluplné a opodstatněné.
| 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 |
| Acute injection toxicity/pathogenicity, rodents | OPTTS 885.3200 |
| Acute oral toxicity/pathogenicity, rodents | OPTTS 885.3300 |
| 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 |
| Gene mutation in mammalian cells (MLA) in vitro | OECD TG 476, ICH S2(R1), ISO 10993-3 |
| Cytotoxicity in vitro | ISO 10993-5 |
* Poskytovaná ve spolupráci nebo jako subdodávka
| 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) |
* Poskytovaná ve spolupráci nebo jako subdodávka
| 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 I model (rats) | |
| Diabetes type II model (non-human primates) | |
| Chronic glaucoma model (dogs) | |
| Acute contact dermatitis model (pigs) | |
| Arthritis model (rodents) | |
| Liver ischemia/reperfusion injury model (dogs) | |
| Experimental myocardial infarction model (dogs, pigs) | |
| Balloon vascular injury model (non-human primates) | |
| Chronic traumatic spinal cord injury model (pigs) | |
| Transgenic Huntington’s disease model (pigs) | |
Fyzikálně - chemické testy a ekotoxikologie *
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
| Fyzikálně - chemické vlastnosti* | |
|---|---|
| Melting Point | OECD 102 |
| Melting Point | OECD 102 |
| Boiling Point | OECD 103 |
| Boiling Point | OECD 103 |
| Relative Density | OECD 109 |
| Relative Density | OECD 109 |
| Vapor Pressure | OECD 104 |
| Vapor Pressure | |
| Surface Tension | OECD 115 |
| Water solubility | OECD 105 |
| Water solubility | OECD 105 |
| Partition coefficient | OECD 117 |
| Partition coefficient | OECD 107 |
| Adsorption/Desorption | OECD 121 |
| Viscosity | EN ISO 3140 |
| Flash point, liquides | EU A.9 |
| Dissociation constants in water | OECD 112 |
| Flammability, solids | EU A.10 |
| Explosive properties | EU A.14 |
| Self-ignition temperature, solids | EU A.16 |
| Oxidizing properties, solids | EU A.17 |
| Partical size distribution | ISO 13320-1 |
| Dissociation constants in water | OECD 112 |
| Hydrolyis | OECD 111 |
| Hydrolyis | OECD 111 |
| Pyrophoric properties of solids and liquids | EU A.13 |
* Služba je poskytována jako subdodávka
| Biodegradabilita* | |
|---|---|
| Ready Biodegradability: Closed Bottle Test | OECD 301D |
* Služba je poskytována jako subdodávka
| Ekotoxikologické studie* | |
|---|---|
| Daphnia Acute Immobilization | OECD 202 |
| Algae Growth Inhibition | OECD 201 |
| Fish Acute Toxicity | OECD 203 |
| Earthworm acute toxicity | OECD 207 |
* Služba je poskytována jako subdodávka
