Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers.

@article{Lubenau2009BioequivalenceOT,
  title={Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers.},
  author={Heinz Lubenau and Audrius Sveikata and Gintautas Gumbrevi{\vc}ius and Jurate Macijauskiene and Vidmantas Fokas and Saulius Kazlauskas and Vytautas Janulionis},
  journal={International journal of clinical pharmacology and therapeutics},
  year={2009},
  volume={47 4},
  pages={275-82}
}
OBJECTIVE The objective of the study was the demonstration of bioequivalence of two recombinant human granulocyte colony-stimulating factor (G-CSF) formulations after subcutaneous administration of 5 microg/kg and 10 microg/kg comparing their pharmacokinetic and pharmacodynamic profiles in healthy subjects. METHODS This was a randomized, single dose, two-period cross-over, two-arm study with a 14 days wash-out period. In total 56 subjects were included, 28 in each dosage cohort (5 microg/kg… CONTINUE READING
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