对于人种差异实验，CFDA的指导方针是没有这一块的要求，我们是根据之前

For the experiments ethnic differences, CFDA guidelines are not requirements of this piece, it is based on prior verification requirements CFDA designed experiments, and Section 8.12 method validation program has been described in detail how the verification experiment should be validated and the sponsor is agree with this approach. <br><br>For description of the inspection Blank plasma 2018 only refers to the difference of the two plasma. There is no requirement to do selective experiments.

For human-to-human difference experiments, the CFDA guidelines are not required for this block, we are designed to be based on previous CFDA verification requirements, and section 8.12 of the Methodology Verification Program has described in detail how the validation experiment should be validated, and the sponsor agrees with this approach.<br><br>For the 2018 audit, blank plasma is described as simply a difference between the two plasmas. There is no requirement to do selective experiments.

As for the ethnic difference experiment, the guideline of CFDA is that there is no such requirement. We designed the experiment according to the previous CFDA verification requirements, and chapter 8.12 of the methodology verification scheme has described in detail how the verification experiment should be verified, and the sponsor agrees with this approach.<br>The description of blank plasma in the audit of 2018 only refers to the difference between the two kinds of plasma. There is no requirement for selective experiments.<br>