ADaM Population Pharmacokinetics (popPK) Implementation Guide

Comments Due By

 

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.

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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.