Pharmacokinetic comparison of two recombinant human granulocyte colony-stimulating factor after subcutaneous administration in rabbits.
A pharmacokinetic comparison between two formulations (LeukoCIM, CIMAB SA versus Neupogen, Hoffman-La Roche, licensed by Amgen) of recombinant human granulocyte colony-stimulating factor (rhG-CSF) using non-compartmental analysis was performed in male F1 rabbits after a single subcutaneous 11.5 microg/kg dose to help decide whether to conduct further comparability tests. Unlike the absorption phase, a statistical difference was not detected between Neupogen and LeukoCIM for clearance (18.69+/-11.83 versus 28.42+/-12.11 mL/h/kg, P=0.22). In addition, using a multivariate statistical analysis by independent samples test, a significant difference was not found between the two formulations (P=0.88). Finally, the results obtained in this study confirmed the pharmacokinetic comparability between both formulations, supporting the claim for further assessments following the current protocol on biogeneric equivalence.
Ducongé
Jorge
J
Department of Pharmacology and Toxicology, Center for Biological Evaluation and Research, Institute of Pharmacy & Foods, University of Havana. jduconge@yahoo.com.mx
Rodríguez-Vera
Leyanis
L
Valenzuela
Carmen
C
Alvarez
Daniel
D
Ramírez
Omar
O
de la Luz-Hernández
Kathya R
KR
Rabeza-Legón
Estela Y
EY
Casacó
Angel
A
Fernández-Sánchez
Eduardo
E
D000818:Animals; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D015999:Multivariate Analysis; D011817:Rabbits; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor