Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
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QC/QA of the Analysis Dataset<br />
SAS Dataset(s) from<br />
Locked Clinical Database<br />
Import Data<br />
Merge<br />
Transform<br />
…..<br />
Exploratory graphs<br />
Detect outliers<br />
…<br />
dm.sas7bdat<br />
cm.sas7bdat<br />
ra.sas7bdat<br />
…………….<br />
Locked Dataset<br />
Ready for Pop PK<br />
Analysis<br />
Dataset<br />
construction<br />
<strong>Pharsight</strong><br />
Scientist 1<br />
Construction<br />
of Dataset 1<br />
Authenticator<br />
Print and sign<br />
scripts verify … <br />
slide 23<br />
<strong>Pharsight</strong><br />
Scientist 2<br />
Deconstruction<br />
of Dataset 1<br />
Construction of<br />
Dataset 2<br />
QC<br />
Quality Control<br />
(Comparison)<br />
QA<br />
• Comparison of deconstructed<br />
Verification of Quality<br />
Dataset with source SAS files<br />
Control, Comparison<br />
• Comparison of the two datasets<br />
and Reconciliation<br />
and reconciliation<br />
QA<br />
Reviewer<br />
Comments QC QA<br />
QA<br />
Comments <br />
© <strong>Pharsight</strong> <strong>Corporation</strong> All Rights Reserved<br />
Quality<br />
Assurance
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