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. 2018 Nov 26;21(1):6.
doi: 10.1208/s12248-018-0269-7.

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

Guohua An  1 , Robert L Schmidt  2 , Donald M Mock  3 , Peter Veng-Pedersen  4 , John A Widness  2
Affiliations

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

Guohua An et al. AAPS J. .
No abstract available

Keywords: erythropoietin; overlooked issues; pharmacokinetic data interpretation; protein drugs.

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Figures

Figure 1.
Figure 1.
The assay signals of the MSD standards, 1st IS and 3rd IS of EPO within the same plate (Top: MSD plate 2; Bottom, MSD plate 31). Each sample was assayed twice within each plate and experiment was repeated using two plates (MSD plate 2 and MSD plate 31).
Figure 2.
Figure 2.
Comparison of EPO concentrations (mU/ml) measured using MSD method (y-axis) vs RIA method (x-axis). Each sample was measured twice. T test was performed on the slop coefficient; p<0.001 MSD method: The plasma concentration of Epo was determined using a commercial electrochemiluminescence detection plate assay (Human Hypoxia Serum/Plasma Kit #K15122C, Meso Scale Discovery, Rockville, MD) following the manufacturer’s recommended procedure. The assay covered an expansive dynamic range (2.4 to 10,000 mU/mL) with an LLOQ of 2.0 mU/mL. Inter-assay variation % CV and intra-assay % CV averaged 14.0% and 4.6%, respectively. RIA method: The plasma concentration of Epo was measured using a double-antibody radioimmunoassay (7, 10). The linear range of the assay was 4-62.5 mU/mL. The LLOQ of the assay is 1.15 mU.mL. Inter-assay variation % CV and intra-assay % CV averaged 6.4% and 3.5%, respectively.
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References

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