Table 6.

Typical study design for main repeat dose toxicity study

Dose group	Low	Medium	High	Control
No. of animals	4M + 4F	4M + 4F	4M + 4F	4M + 4F
No. of recovery	Up to 2M + 2F	Up to 2M + 2F	Up to 2M + 2F	Up to 2M + 2F
	Total for one study			48
Maximum total per program (three studies)				144

*There is variation in approach between companies; not all companies carry out the studies exactly as described in this table.