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Additionally, it’s noted that “based on body surface area, the highest tested [subcutaneous] dose (1 mg/kg/day) administered for the longest time (26 weeks) to mice, rats, and monkeys provides safety margins of ~3-fold, 6-fold, and 12-fold to the daily human [subcutaneous] dose of 1.6 mg, respectively.” Reproductive and developmental toxicity: SciClone Pharmaceuticals, a biopharmaceutical company, claimed to have “successfully completed” adequate reproductive toxicology studies on the use of TA-1 in rodents, but the FDA notes that no published nonclinical studies with the data could be identified
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