کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9901405 | 1545419 | 2005 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Pharmacokinetic comparison of two recombinant human granulocyte colony-stimulating factor after subcutaneous administration in rabbits
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوتکنولوژی یا زیستفناوری
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 61, Issue 3, October 2005, Pages 142-148
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 61, Issue 3, October 2005, Pages 142-148
نویسندگان
Jorge Ducongé, Leyanis RodrÃguez-Vera, Carmen Valenzuela, Daniel Álvarez, Omar RamÃrez, Kathya R. de la Luz-Hernández, Estela Y. Rabeza-Legón, Ángel Casacó, Eduardo Fernández-Sánchez,