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Study length
Briumvi: how long were the pivotal tox studies?
ublituximab · CD20
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Study length
Skipped studies
First dose
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Longest pivotal study
26 weeks
“General toxicology studies of up to 26 weeks’ duration were conducted in cynomolgus monkeys.”
✓ Verified
FDA pharmacology/toxicology review, p. 50
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Pivotal GLP studies
GLP 4-, 13- and 26-week intravenous toxicity studies in cynomolgus monkeys
“The sponsor conducted 4-, 13-, and 26-week GLP intravenous toxicity studies in cynomolgus monkey.”
✓ Verified
FDA pharmacology/toxicology review, p. 3
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Route in tox
Intravenous (short infusion of 3 or 15 min, or slow bolus)
“For these studies, ublituximab was administered intravenously, either by short infusion (3 or 15 min) or slow bolus.”
✓ Verified
FDA pharmacology/toxicology review, p. 3
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Not stated in public reviews
Summary across all 117 monoclonal antibodies →
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