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Activity Number:
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614
- Pharmacometric Programming
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 3, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Statistics and Pharmacometrics Interest Group
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Abstract #324185
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Title:
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Data Standards for Pharmacometric Analysis Data Sets
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Author(s):
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Neelima Thanneer*
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Companies:
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Bristol-Myers Squibb
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Keywords:
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PKPD ;
population pharmacokinetics ;
exposure-response ;
data standards ;
pharmacometrics ;
electronic submission
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Abstract:
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Timely availability of high quality data sets is essential for accurate and impactful pharmacometric (Pm) analyses. Improvements in timeliness and quality are achieved by standardizing data set preparation for Pm analyses, particularly when the data set requires derivations and imputations of variables and data not available in the source data. Issues related to data imputation are particularly accute for population pk data sets as complete dosing history is not generally available in the source data. This presentation will describe the data standards to handle the issues related to missing and inadequate data. Improvements to CRF design to better capture the required information for pharmacometric analysis and update on International Society of Pharmacometrics [ISoP] data standards for population PK datasets.
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Authors who are presenting talks have a * after their name.
