Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
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RAS Typical <strong>Population</strong> Pharmacokinetics Workflow<br />
Sponsor Data<br />
Analytic Lab<br />
QA<br />
Locked SAS Dataset(s) (CDISC)<br />
Analytic Report<br />
dm.sas7bdat<br />
cm.sas7bdat<br />
RAS<br />
Protocol<br />
Sponsor<br />
ra.sas7bdat<br />
QA<br />
ex.sas7bdat<br />
Clinic<br />
pp.sas7bdat<br />
Clinical Deviations<br />
…………..<br />
…………..<br />
…………..<br />
…………..<br />
…………..<br />
Work Plan<br />
Protocol<br />
Import Data<br />
Merge<br />
Transform<br />
…..<br />
Exploratory graphs<br />
Detect outliers<br />
…<br />
Analysis<br />
1. NCA<br />
•Preclinical<br />
•Phase I<br />
•Phase II<br />
Reporting<br />
1. Writing<br />
•Scientific<br />
•Pharmacological<br />
•Medical<br />
2. IVIVC Formulation<br />
2. Quality Assurance<br />
Dataset<br />
construction<br />
3. Regulatory Pop PK-<br />
PD Analysis<br />
Results<br />
3. Formatting<br />
Clinical Study<br />
Reports<br />
slide 20<br />
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