However, the critical limitation remains the near-total absence of rigorous human clinical trial data
Dose Range: 50100 mg daily
In addition, included were, i.e., 4-week intravenous toxicity in rats followed by 4 weeks of recovery, 4-week intravenous toxicity in dogs, sub-acute (14 days) intracolonic toxicity study in rats and Beagle dogs, a repeated dose (28 days) dermal toxicity study in Wistar rats, chromosome aberrations in human lymphocytes cultured in vitro, an Ames test, a micronucleus test, female fertility and early embryonal development after intravenous administration to rats, embryofetal development after intravenous administration to rats (including toxicokinetics in pregnant animals and placental transfer), embryofetal development after intravenous administration in New Zealand White rabbits, cardiovascular and respiratory systems in anesthetized dog, a sensitization study in guinea pigs (Maximization test), and an acute eye irritation/corrosion study in albino rabbits
Sterile water for injection is preservative-free and intended for single-use preparation only
Injecting a forceful stream of water directly onto the lyophilized powder can physically damage the delicate peptide structure through shearing forces