GENERAL TOXICOLOGY
BioTest covers core battery of non clinical safety tests and studies providing the substantial information on the drugs to support phases I - III of clinical trials 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 experinece with variety of compounds and therapeutic areas.
The substantial advantage is long experience in the work with dogs and non-human primates.
BioTest 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.
BioTest also strongly streams to use alternative methods of testing according to OECD, and/or ECVAM whenever it is rational and justified.
| Acute toxicity studies | |
| Acute toxicity/pathogenicity (oral, dermal, injection), Rodents, non-rodents | OECD 402, 420, 423, 425, EU B1. bis, B1.tris, B.3, OPTTS 870-110, 885.3200, 885.3150, 885.3300, ISO 10993-11 |
| Skin/Eye irrtability, rabbit | OECD 404, 405, EU B.4, B.5, ISO 10993-10, OPTTS 870-2500, 870-2400 |
| Skin sensitization, allergization, Guinea pig | EU B.6 1992, ISO 10993-10 OECD 406 1992, OPTTS 870-2600 |
| MTD/DRF, Extended single dose studies, rodents, non-rodents | CPMP/EWP/205/95, CPMP/SWP/997/96, CPMP/ICH/286/95, M3(R2) |
| Sub-acute, sub-chronic and chronic toxicity studies | |
| Sub-acute (7 - 21 days), Sub-chronic (28 - 90 days), chronic (6 - 12 months) toxicity studies, rodents, non-rodents | OECD 408, 409, 14, 411, EU B.7, B.9, B.26, B27, B.28, B.30, CPMP/SWP/1041/99, OPTTS 870-3050, 870-3100, 870-4100 |
| Preclinical safety evaluation of biotechnology-derived pharmaceuticals, rodents, non-rodents | CPMP/ICH/302/95 |
| Toxicokinetic/Pharmacokinetic/Bioequivalence (BE)/Bioavailability (BA) studies | |
| Toxicokinetic/Pharmacokinetic studies (biological part), rodents, non-rodents | OECD 417, EU B.36 1996, CPMP/ICH/384/95, OPTTS 870-7485, 870-8223 |
| BE/BA for veterinary medicinal products (biological part) | EMEA/CVMP/016/00 |
| PK studies in target animal species (biological part) | EMEA/CVMP/133/99, OPTTS 870-7485, 870-8223 |
| Toxicity to reproduction | |
| Prenatal developent toxicity study | ICH 4.1.3, OECD 414 |
| One-generation reproduction toxicity study | ICH 4.1.3, OECD 415 |
| Two-generation reproduction toxicity study | ICH 4.1.3, OECD 416 |
| Reproduction/developmental toxicity screeneing test | ICH 4.1.35, OECD 421 |
| Combined repeated dose toxicity study with reproduction/developmental toxicity screening test | ICH 4.1.3, OECD 422 |
| Carcinogenicity | |
| Carcinogenicity | OECD 451 |
| Combined chronic toxicity/carcinogenicity | OECD 453 |