Overlooked Issues on Pharmacokinetics Data Interpretation of Protein Drugs—a Case Example of Erythropoietin
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Recombinant human erythropoietin (rhEPO) has been used for over 30 years as a major therapeutic agent for treatment of anemia caused by chronic kidney disease and chemotherapy. During this period, a great deal has been learned about rhEPO and its physiological role in the regulation of erythropoiesis (1). Nevertheless, several issues remain to be resolved in the rhEPO pharmacokinetics arena due to the challenges of unifying different assays and different EPO standards. In this communication, we report two frequently overlooked issues on pharmacokinetics data interpretation of rhEPO and offer solutions to ensure reliable estimation of the pharmacokinetics parameters. To the best of our knowledge, there have been no reports on these important issues.
BACKGROUND OF EPO MEASUREMENTS
Unlike small-molecule compounds whose amounts are expressed in grams or moles, EPO amounts are expressed in units (U), which is defined based on EPO’s biological activity determined by in vivo bioassays (2)....
KEY WORDSerythropoietin overlooked issues pharmacokinetic data interpretation protein drugs
This work was supported in part by National Institutes of Health (NIH) US Public Health Service Program Project Grant P01 HL046925 and the National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number U54TR001356.
Compliance with Ethical Standards
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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