• 2 x 4 week rat GLP one scheduled after the other to check on result/work consistency
• 1 x 4 week dog GLP study
• 1 x 4 week monkey GLP study
• 1 x 3 or 6 month rat GLP study

Proposed Study Group Sizes & Misc:

• For each study, four dose groups including control, low, medium and high doses, both genders?
• For rat studies assume 10 animals/group/gender, for large animals assume 2-3 animals/group/gender
• Assume full TK, clin path, and histopathology conducted within the institution, however assume pathologists at the member companies will perform the peer review

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