Comparison of the Pharmacokinetic-Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers.
Seokuee KimTaegon HongJae-Wook KoWooseong HuhJung-Ryul KimPublished in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2019)
The test and reference darbepoetin alfa formulations had similar PK, PD, and safety profiles. Thus, it is expected that the two formulations are able to be used interchangeably in clinical settings. ClinicalTrials.gov Identifier: NCT03542916.