A large multicenter, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with European and United States reference pegfilgrastim.

Gordon P. Otto,Roumen Nakov,Steven Schussler,Stefanie Schier-Mumzhiu,Celine Schelcher,Sven D. Koch,Andrej Skerjanec,Jessie Wang,Andriy Krendyukov,Anne Bellon

A large multicenter, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with European and United States reference pegfilgrastim.

2019

Gordon P. Otto
Roumen Nakov
Steven Schussler
Stefanie Schier-Mumzhiu
Celine Schelcher
Sven D. Koch
Andrej Skerjanec
Jessie Wang
Andriy Krendyukov
Anne Bellon

e23118Background: Similarity of the pharmacokinetic (PK)/pharmacodynamic (PD) profiles of Sandoz proposed biosimilar pegfilgrastim and EU-reference biologic was confirmed in a pivotal Phase I study...

Keywords:

Physical therapy
Biosimilar
Crossover study
Pediatrics
Pegfilgrastim
Pharmacokinetics
Medicine
Pharmacodynamics
healthy volunteers
double blind
Oncology
Internal medicine
phase i study

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