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Overlooked Issues on Pharmacokinetics Data Interpretation of Protein Drugs—a Case Example of Erythropoietin

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References

  1. Fried W. Erythropoietin and erythropoiesis. Exp Hematol. 2009;37(9):1007–15. https://doi.org/10.1016/j.exphem.2009.05.010.

    Article  CAS  PubMed  Google Scholar 

  2. Jelkmann W. Efficacy of recombinant erythropoietins: is there unity of international units? Nephrol Dial Transplant. 2009;24(5):1366–8. https://doi.org/10.1093/ndt/gfp058.

    Article  CAS  PubMed  Google Scholar 

  3. Storring PL, Gaines Das RE. The International Standard for Recombinant DNA-derived Erythropoietin: collaborative study of four recombinant DNA-derived erythropoietins and two highly purified human urinary erythropoietins. J Endocrinol. 1992;134(3):459–84. https://doi.org/10.1677/joe.0.1340459.

    Article  CAS  PubMed  Google Scholar 

  4. Wognum A. Erythropoietin mini-review. https://www.stemcellcom/erythropoietin-lphtml. 2015.

  5. NIBSC. Third WHO International Standard for Erythropoietin, recombinant, for bioassay NIBSC code 11/170. 2012:version 1.0.

  6. NIBSC. WHO International Standard Erythropoietin, Human recombinant, NIBSC code 88/574. 2008:version 4.0.

  7. Widness JA, Schmidt RL, Hohl RJ, Goldman FD, Al-Huniti NH, Freise KJ, et al. Change in erythropoietin pharmacokinetics following hematopoietic transplantation. Clin Pharmacol Ther. 2007;81(6):873–9. https://doi.org/10.1038/sj.clpt.6100165.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Widness JA, Veng-Pedersen P, Peters C, Pereira LM, Schmidt RL, Lowe LS. Erythropoietin pharmacokinetics in premature infants: developmental, nonlinearity, and treatment effects. J Appl Physiol. 1996;80(1):140–8. https://doi.org/10.1152/jappl.1996.80.1.140.

    Article  CAS  PubMed  Google Scholar 

  9. Widness JA, Schmidt RL, Veng-Pedersen P, Modi NB, Sawyer ST. A sensitive and specific erythropoietin immunoprecipitation assay: application to pharmacokinetic studies. J Lab Clin Med. 1992;119(3):285–94.

    CAS  PubMed  Google Scholar 

  10. Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, et al. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 2011;13(1):99–110. https://doi.org/10.1208/s12248-011-9251-3.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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Funding

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.

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Correspondence to Guohua An.

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An, G., Schmidt, R.L., Mock, D.M. et al. Overlooked Issues on Pharmacokinetics Data Interpretation of Protein Drugs—a Case Example of Erythropoietin. AAPS J 21, 6 (2019). https://doi.org/10.1208/s12248-018-0269-7

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