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Activity Number:
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166
- Non-Clinical Statistics, Personalized Medicine, and Other Topics
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Type:
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Contributed
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Date/Time:
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Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Section for Statistical Programmers and Analysts
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Abstract #318682
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Title:
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WITHDRAWN: Challenges and Strategies of Handling of PKPD Data in CDISC Standards
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Author(s):
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Sanjeeva Thalla
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Companies:
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COVANCE
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Keywords:
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PKPD Data;
SDTM PC, PP datasets;
ADaM ADPC, ADPP datasets;
PK Analysis;
challenges and strategies of PK Data handling;
CDISC
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Abstract:
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Pharmacokinetic (PK) analysis is a crucial segment of initial stages of drug development and clinical research studies. Pharmacokinetic modelling is performed by non-compartmental or compartmental methods. Non-compartmental methods measure the exposure to a drug by estimating the area under the curve of a concentration-time graph with the trapezoidal rule. USFDA advocates generating Study Data Tabulation Model PC and PP, Analysis Data Model ADPC and ADPP domains as part of PK analysis. Non-compartmental technique is widely used process for PK analysis. This paper will give brief description of some of the challenges and strategies of the PKPD data handling and programming for CDISC datasets. Also emphasizes the PK Data handling and creating datasets for PK analysis and PKPD modelling.
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Authors who are presenting talks have a * after their name.
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