Zaynich: which risks did reviewers probe?

“Distribution: 100 mg/kg [14C]-WCK 5107, administered intravenously, distributed in the highest concentrations (> 200 to 4420 mcg equivalents/g tissue) to kidney (medulla and inner and outer cortex), plasma, and urinary bladder wall.”

“The exposure margins for the lowest zidebactam dose associated with renal tubular histopathology relative to the recommended clinical dose of zidebactam (1 g administered every 8 hours) are 2.7 and 2.3 for male and female dogs respectively based on plasma AUC exposure (Table 1).”