In meeting the compliance with CDISC data standards and obtaining PK parameters submission ready domains, PP and ADPP, Pharmacokinetics group at Celgene has developed a process to ensure that NCA (Non-Compartment Analysis) PK parameter analysis using WinNonlin, the NCA defaulted PK parameter names are accurately mapped and compliant to the PK parameter codelist and controlled terminology defined by CDISC. 1 PharmaSUG Paper PO01 CDISC Compliant NCA PK Parameter Analysis When Using Phoenix WinNonlin ABSTRACT Renfang Hwang, Celgene Corporation, Summit, New Jersey Mapping the Non-Compartmental Analysis (NCA) PK parameter defaulted names when using Phoenix WinNonlin to CDISC compliant PK parameter names needs to involve the pharmacokineticist to avoid confusion and incorrect report on PK parameter analysis.
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