#Winnonlin archive

SDTM: Study Data Tabulation Model, ADaM: Analysis Data Model, CRF: Case Report Form data, Bioanalysis: Bioanalytical results dataset, WinNonlin: PK analysis software, TFLs: Tables, figures and listings.ДЄs illustrated in Figure 1, there are currently two primary SDTM domains dedicated to the submission of PK data: the Pharmacokinetic Concentration (PC) domain and the Pharmacokinetic Parameter (PP) domain. An example workflow incorporating SDTM and ADaM datasets in a typical CDISC compliant Pharmacokinetic (PK) analysis is illustrated in Figure 1.ДЇigure 1 Example SDTM and ADaM workflow associated with the submission of CDISC compliant PK datasets The CDISC standards most associated with the analysis and submission of PK data are the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.ДЄn important component of many clinical studies is the collection of Pharmacokinetic (PK) blood samples and the subsequent analysis of PK data.

#Winnonlin archive

The Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that develops standards to support the acquisition, exchange, submission, and archive of data in clinical research.