| TK/PK/BE/BA studies |
| Toxicokinetic/Pharmacokinetic studies (biological part), rodents, non-rodents |
EU B.36 1996, CPMP/ICH/384/95
OECD 417 1984, 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 |
| Other non-cinical studies |
| Non-clinical safety studies |
CPMP/ICH/286/95
CPMP/ICH/302/95
CPMP/SWP/2599/02 |
| Safety pharmacology studies |
CPMP/ICH/539/00
CPMP/EWP/205/95
CPMP/ICH/423/02 |
| Non-clinical local tolerance studies |
CPMP/SWP/2145/00
ISO 10993-6 |
| Preclinical pharmacological and toxicological testing of vaccines |
CPMP/SWP/465/95, CVMP/IWP/52/97 |
| Immunogenicity/Immunotoxicity studies |
EMEA/CHMP/167235/04, CVMP/004-04, OPTTS 870-7800 |
| Non-clinical testing of vaccines (human/veterinary), challenge studies
Rodents, non-rodents |
CHMP/EWP/463/97, CPMP/BWP/2289/01, CPMP/SWP/465/95 |
| Challenge, immunization and safety studies of anti-influenza vaccines, ferrets, rhesus monkeys |
EMEA/CHMP |
| Pre-clinical safety evaluation of biotechnology-derived pharmaceuticals, rodents, non-rodents |
CPMP/ICH/302/95 |
| Screening of potential cytostatics |
| Anti-tumor effectiveness in vitro (MTT test) and in vivo (transplanted tumors, SCID, Nu/nu mice)> | |
| Immunization studies and customized antibody production |
| Anti-GB2, Anti-GB1PAN, Anti-GB1b, Anti-GB1a | |
| CRIP 1a, CRIP 1b | |
| mGluR1a, mGluR1b, mGluR1PAN | |
| Ascitic fluid production | |
| Diabetes model |
| Diabetes Type II model in Rhesus monkeys. This is a result of long-tem cooperation in the model development. Rhesus macaques are involved. Today we have a group of 20 monkeys with shifted glucose level | |
| Diabetes Type I model - STZ induced model in Wistar rats | |
