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The study was conducted at a single phase 1 unit in the United States
Subjects were administered study medication for 5 consecutive days at a dose of 5 mcg/kg/day.
Primary PD endpoint of CD34+ cells for PD population was similar across treatment groups.
PD population: n=56 (NIVESTYM); n=56 (Neupogen).
PD equivalence was concluded if the 90% confidence intervals for both AUECCD34+ and CD34+max were completely contained within the prespecified acceptance limits of 0.80-1.25.
Studies in support of biosimilarity in healthy volunteers
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