Pharmacokinetic comparison of two recombinant human granulocyte colony-stimulating factor after subcutaneous administration in rabbits

• Published in: European journal of pharmaceutics and biopharmaceutics Vol. 61; no. 3; pp. 142 - 148
• Main Authors: Ducongé, Jorge, Rodríguez-Vera, Leyanis, Valenzuela, Carmen, Álvarez, Daniel, Ramírez, Omar, de la Luz-Hernández, Kathya R., Rabeza-Legón, Estela Y., Casacó, Ángel, Fernández-Sánchez, Eduardo
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-10-2005
• Subjects: Animals; Area Under Curve; Chemistry, Pharmaceutical; Clearance; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - pharmacokinetics; Humans; Injections, Subcutaneous; Male; Multivariate Analysis; Pharmacokinetics; Rabbits; Recombinant human granulocyte colony-stimulating factor; Recombinant Proteins; Recombinant human granulocyte colony-stimulating factor; Pharmacokinetics; Clearance
• ISSN: 0939-6411; 1873-3441
• DOI: 10.1016/j.ejpb.2005.06.003

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
μg/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.