Collaborative study for the establishment of erythropoietin BRP batch 4.

@article{Burns2015CollaborativeSF,
  title={Collaborative study for the establishment of erythropoietin BRP batch 4.},
  author={Chris Burns and Adrian F. Bristow and Arnold Daas and Ang{\`e}le Costanzo},
  journal={Pharmeuropa bio & scientific notes},
  year={2015},
  volume={2015},
  pages={246-53}
}
The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for erythropoietin (EPO) is used as a working standard for potency determination of EPO preparations by in vivo bioassay as prescribed in the Ph. Eur. monograph Erythropoietin concentrated solution (1316). The BRP batch 3 was calibrated in 2006 and its stocks are depleted. The European Directorate for the Quality of Medicines & HealthCare (EDQM) thus initiated a project to calibrate a replacement batch in International… CONTINUE READING