Toxicology studies (GLP)
- Single dose toxicity study in most relevant species (mice/rats/dogs or mini pig)
- Repeat dose toxicity study with recovery & immunogenicity (mice/rats/rabbits/dogs or mini pig)
- Local tolerance study in rabbits
- Juvenile toxicity studies in rodents
Reproduction studies (GLP)
- Fertility and early embryonic development to implantation (SEG-I) in rats
- Prenatal developmental study (SEG-II) in rats and rabbits
- Peri-natal and post-natal developmental study (SEG-III) in rats
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