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Bioassay: Validation Analyst

Dear Forum Members,

1.What could be parameters that we have to validate for Microbiological Bioassay?

As far as my understanding is concerned, we have look for Specificity, linearity and Precision.

2.What are the number of replicates that we need to consider for precision and whether we need to prepare the standard and sample solutions freshly or not?

  1. What is the acceptance criteria to be set for Standard Deviation, RSD, and Cofficient of Variance? Please let me know if any other criteria are missing?

Looking forward for a reply.

kvkiran