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In this section: Biomarker Qualification Program

FDA Reviews of Qualified Biomarker: Plasmodium 18S rRNA/rDNA

Office of Clinical Pharmacology Review (PDF - 446KB)
Review Memo: Plasmodium falciparum 18s rRNA/rDNA gene, A-Type Biomarker Qualification (PDF - 95KB)
CDER Review (PDF - 911KB)
CDRH Review : DDTBMQ000044 (PDF - 528KB)
Qualification Letter: DDTBMQ000044 (PDF - 59KB)
Supplementary Material (PDF - 9MB)

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