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Paul Connolly Christine Edwards Mark Ammerman Amy Sheehan Brittany Kravets , ,Scott Crain _ Frances Crespi Devon Ingram Christa Gallant Title Vice President Scientist Technical Lead-LC/MS Technician Sample Custodian - Associate Scientist Technician Technician Technician Technician Technician Exygen Research Page 6 of 110 P-6 TABLE OP CONTENTS Page TITLE PAGE.........................................................................................................................1 GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT.............................. 2 QUALITY ASSURANCE STATEMENT......................... 3 CERTIFICATION OF AUTHENTICITY.......................... 4 STUDY IDENTIFICATION................................................................................................. 5 PROJECT PERSONNEL...................................................................................................... 6 TABLE OF CONTENTS...................................................................................................... 7 LIST OF TABLES................................................................................................................ 8 LIST OF FIGURES...................................................... 9 LIST OF APPENDICES..................................................................................................... 10 1.0 SUMMARY............................................................ 11 2.0 OBJECTIVE.................................................................................................................11 3.0 INTRODUCTION........................................................................................................ 11 4.0 ANALYTICAL TEST SAMPLES............................................................................ 12 5.0 REFERENCE MATERIAL.........................................................................................12 6.0 DESCRIPTION OF ANALYTICAL METHOD.........................................................13 6.1.

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