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Ineffective Audit Trail Review: The fact that the FDA investigator discovered this trend, while the firm had not, indicates a failure to "exercise appropriate controls" under 211.68(b)

Excretion Pathways Based on the peptide structure and pharmacokinetic characteristics: Primary elimination likely occurs through hepatic metabolism and biliary excretion Renal excretion of intact peptide appears minimal given the molecular size and protein binding Clearance rates remain consistent across multiple doses, indicating no accumulation beyond steady-state Terminal elimination phase extends several days after the last dose The favorable pharmacokinetic profile, characterized by predictable absorption, limited drug interactions, and steady-state maintenance with weekly dosing, supports the clinical development strategy and dose escalation regimens employed in phase 2 and phase 3 trials

Keenan MJ, Zhou J, McCutcheon KL, Raggio AM, Bateman HG, Todd E, et al