The OSIRIS Weight of Evidence approach: ITS for the endpoints repeated-dose toxicity (RepDose ITS)

- Development of an Integrated Testing Strategy (ITS) for repeated-dose toxicity.
- Evaluation whether in vivo non-guideline studies are reliable or new testing is recommended.
- Three aspects are assessed: the documentation of the study, the quality of the study design and the scope of examination.
- Proposed non-testing methods: category approach, read across and TTC concept.