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Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers

Khandoozi, S.R. and Shahbazi, M. and Amini, H. (2020) Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers. Clinical Pharmacology in Drug Development.

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Abstract

This study aimed to compare the pharmacokinetic, pharmacodynamic, and safety profiles of a proposed biosimilar and innovator filgrastim therapeutics in healthy volunteers. In a crossover design, 23 subjects received a single subcutaneous injection of 300-µg filgrastim, followed by a 7-day washout period. Assessed pharmacokinetic parameters were the maximum observed filgrastim serum concentration (Cmax), time to reach Cmax (tmax), the area under the concentration-time curve (AUC), and elimination half-life. Pharmacodynamics were assessed by the maximum observed absolute neutrophil count effect (Emax), tmax,E (time to reach Emax), and the area under the effect of the absolute neutrophil count �time curve. The test/reference ratio (90 confidence intervals) of Cmax of 0.992 (0.860-1.143), AUC0�inf of 0.995 (0.891-1.111), Emax of 0.952 (0.841, 1.078), and area under the effect of the absolute neutrophil count �time curve from time zero to 96 hours of 0.939 (0.854-1.032), were all well within the predefined equivalence boundaries of 80 and 125. Obtained values for tmax (�4 hours), tmax,E (�15 hours), and elimination half-life (�3.5 hours) were comparable between 2 treatment groups. The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products. Altogether, the results suggested a high similarity of the proposed biosimilar to the innovator filgrastim in healthy volunteers. © 2020, The American College of Clinical Pharmacology

Item Type: Article
Additional Information: cited By 0
Subjects: سیستم های خونی و لنفاوی WH
فارماکولوژی QV
> دانشکده داروسازی > فارماکولوژی QV

آسیب شناسی QZ
میکروب شناسی وایمنی شناسی QW
مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 05 Sep 2020 06:33
Last Modified: 05 Sep 2020 06:33
URI: http://eprints.goums.ac.ir/id/eprint/10767

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