Jul 22, 2008 Views: 470
in-vivo bioassay of EPO
Hi, This is Dr Ramesh working in private biotech. company and we are producing rHu EPO here. For EPO potency is required for release the batch in market. With refer to publication (Barth et al. Journal of AOAC International, Vol.91 No.2, 2008) we are also trying to validation of bioassay in female balb/c mice, But only thing differed is we are doing on single injection of standard solution, remain things are similar, but we are found large variation of retic count in inter group, so we are always failing in fudicial limit while calculating assay. As per Ph. Eu. other parameter like regression, linearity and parallelism are found ok but regression value found very low that is 7-15 only.
So, My questions are
1) Is animal play role for failing of fudicial limit? how much and why? what should be corrective measure?
2) How I control fudicial limit?
Please try to guide me in these era.
Thank you
Ramesh
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