The purpose of the Basic Data Structure for ADaM PopPK Implementation Guide v1.0 is to present the ADaM Basic Data Structure (BDS) and required extensions for popPK. This IG supports many of the variables needed for popPK analysis and provides general naming conventions that can be leveraged in the definition of other variables. It also provides specific guidance for all common variables and may be viewed as the ADaM BDS model plus additional popPK variables.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.