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 | |
