首页> 美国卫生研究院文献>Springer Open Choice >PF-06881893 (Nivestym™) a Filgrastim Biosimilar Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

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PF-06881893 (Nivestym™) a Filgrastim Biosimilar Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

机译：PF-06881893（Nivestym™）一种Filgrastim生物仿制药与美国许可的Filgrastim参考产品（US-Neupogen®）：健康志愿者中单次或多次皮下给药的药代动力学药效学免疫原性和安全性

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BackgroundThree comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen^®) in healthy volunteers (HVs).

机译：背景三项比较临床研究评估了非格司亭生物仿制药PF-06881893（filgrastim-aafi; Nivestym™）与美国许可的参比产品（filgrastim; US-Neupogen ^{>®）在健康志愿者（HVs）中。}

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期刊名称 Springer Open Choice
作者
Hsuan-Ming Yao; Faith D. Ottery; Troy Borema; Stuart Harris; Jeffrey Levy; Tom B. May; Shahrzad Moosavi; Jeffrey Zhang; Martin Summers;
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作者单位

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年(卷),期 -1(33),2
年度 -1
页码 207–220
总页数 14
原文格式 PDF
正文语种
中图分类外科学;
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外文文献

1. Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers [J] . Chungam Choi, Byung Won Yoo, Choon Ok Kim, Drug Design, Development and Therapy . 2018,第InaProgress期

机译：生物仿制药非格司亭与参考产品的比较：健康志愿者中的药代动力学，药效学和安全性
2. Pharmacokinetic and pharmacodynamic properties of a new biosimilar filgrastim TPI G-CSF in comparison to the marketed reference filgrastim Neupogen?: a double-blind, single-dose, two-period crossover trial [J] . Sarfaraz K Niazi Biosimilars . 2015,第3期

机译：新型生物仿制药非格司亭TPI G-CSF与市售参比非格司亭Neupogen ？的药代动力学和药效学性质：双盲，单剂量，两期交叉试验
3. A comparative pharmacokinetic and pharmacodynamic study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese men [J] . LTAMedicalCorporationKyushuClinicalPharmacologyResearchClinic2-13-16, FujiPharmaCo.Ltd., DepartmentofLaboratoryMedicineTheJikeiUniversitySchoolofMedicine Clinical pharmacology in drug development . 2015,第2期

机译：在健康的日本男性中，反复皮下给药后，FSK0808与参比非格司亭的药代动力学和药效学比较研究
4. Safety, tolerability, pharmacodynamics and pharmacokinetics following single subcutaneous dosesof a teverelix depot formulation in healthy male volunteers [C] . C. MacLean, F. Larsen, R. Piechatzek, Annual meeting exposition of the Controlled Release Society . 2005

机译：在健康男性志愿者中单次皮下注射Teverelix储库制剂后的安全性，耐受性，药效动力学和药代动力学
5. Comparison of biosimilar filgrastim with a reference product: pharmacokinetics pharmacodynamics and safety profiles in healthy volunteers [O] . Chungam Choi, Byung Won Yoo, Choon Ok Kim, 2018

机译：生物仿制药非格司亭与参考产品的比较：健康志愿者中的药代动力学药效学和安全性
6. PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers [O] . Hsuan-Ming Yao, Faith D. Ottery, Troy Borema, 2019

机译：PF-06881893（NivEstym™），菲格拉特灭植物生物仿生，与美国许可的菲拉斯摩托夫人参考产品（US-Neupogen®）：药代动力学，药效学，免疫原性和健康志愿者中的单一或多个皮下剂量的安全性

PF-06881893 (Nivestym™) a Filgrastim Biosimilar Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

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