CDISC invites you to to submit comments on the draft version 1.0 of the ADaM Population Pharmacokinetics (popPK) Implementation Guide during Public Review.
The purpose of ADaM popPK Implementation Guide v1.0 is to present the Basic Data Structure (BDS) and the required extensions to support Population Pharmacokinetic (popPK). The ADaM Implementation Guide v1.3 supports many of the variables needed for popPK analysis and provides general naming conventions that can be leveraged in the definition of other variables. The ADaM popPK Implementation Guide will provide specific guidance for all common variables and may be viewed as the ADaM BDS model plus additional popPK variables.
To Provide Comments:
- View the draft: ADaM popPK Implementation Guide v1.0.
- Instructions for providing comments: Instructions for Reviewers
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.