“BI 674304 was evaluated in a pivotal 26-week repeat-dose general toxicity study in CD-1 mice.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗
Pivotal GLP studies
26-week CD-1 mouse study with surrogate BI 674304, IV twice weekly at 10 and 50 mg/kg
“BI 674304 was evaluated in a pivotal 26-week repeat-dose general toxicity study in CD-1 mice. BI 674304 was administered via intravenous injection, twice weekly, at the doses of 0, 10, and 50 mg/kg.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗
Route in tox
Intravenous
“BI 674304 was administered via intravenous injection, twice weekly, at the doses of 0, 10, and 50 mg/kg.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗