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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

(DRM)

3

Accuracy/Recovery:

Precision (RSD

r

):

SMPR: < 2% RSD, MLT range – 0.15-12.4% (all matrices) and 0.15-

1.68% when 2 placebo’s are excluded.

Reproducibility (RSD

R

):

SMPR: <4% RSD, MLT range – 0.95-20.8% (all matrices) and 0.95-

3.89% when 2 placebo’s are excluded.

Recommendation for Designating as Dispute Resolution Method: (Y/N)

Did the Author satisfactorily address ERP’s general comments?

Did the Author satisfactorily address ERP’s specific comments?

Does the method meet the approved SMPR?

Yes

Has the method been performing well in the laboratory?

Would you recommend designating this method as a dispute resolution method to the ERP?

Yes

Final Comments?

I recommend this method for final action status and consideration as a dispute resolution

method.