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This is an example of an ADaM dataset designed to describe the main variables needed to perform a PK Parameter summary. The dataset decribed below is called ADPP and is based on the SDTM PP dataset shown here SDTM Example.Pharmacokinetics Parameters.

The ADaM ADSL associated with this study is not shown. An example on the creation of an ADSL for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New   

Values from ADSL and PP are combined to capture observations that can be summarized. This is just an example and does not mean to indicate that ADPP must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. One item to note is the use of PARQUAL which is not yet included in any ADaMIG but will appear in a future version of the ADaM. 

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adpp.xpt

RowSTUDYIDUSUBJIDTRTAAVISITPARQUALPARAMPARAMCDAVALPPSPECPPSEQPKFL
1APP-123123-0001Drug ADay 1NICOTINEAUC All (h*ng/mL)AUCALL11.4PLASMA3Y
2APP-123123-0001Drug ADay 1NICOTINEMax Conc (ng/mL)CMAX13PLASMA2Y
3APP-123123-0001Drug ADay 1NICOTINETime of CMAX (h)TMAX5PLASMA1Y
4APP-123123-0001Drug ADay 1COTININETime of CMAX (h)TMAX6PLASMA5Y
5APP-123123-0001Drug ADay 1NNNTime of CMAX (h)TMAX7PLASMA6Y
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ADPP Dataset Metadata

ADPP Variable Metadata



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