Review Team (February 2016)

Bio-02 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

TABLE OF CONTENTS

Section

Description

Page

1 2 3 4 5

Introduction References

4 4 4 5 6 6 6 6 6 6 7 8

Scope

Validation Samples

Single Laboratory Validation

5.1 5.2 5.3 5.4 5.5 5.6

Methodology

Specificity / Blanks Identification of biotin Linearity and range Accuracy / Recovery Precision (Repeatability) Summary and conclusion

6

Note only include the relevant topics from the table in the report.

No

Other pages attached:

Yes

Appendix 1: Proposed Method Appendix 2: Reagent Blank Appendix 3: Placebo Appendix 4: Linearity and Slope

Appendix 5: Typical Standard Chromatogram Appendix 6: Typical Sample Chromatogram

5841 v2

Page 3 of 9

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