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(1) For each of the tests outlined in the attached draft monograph, list the performance parameters to be included in the validation.

18 / 01 / 2019 Pharmacy

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Considering the same references in Part 1 above,  
 
(1)    For each of the tests outlined in the attached draft monograph, list the performance parameters to be included in the validation. 
 
(2)    For each of the tests outlined in the attached draft monograph, list the Acceptance Criteria for each performance parameter.  
 
(3)    For the assay, provide a list of points to be considered for the experimental design for each performance parameter


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