Overview of CDISC ADaM Population PK Data Standard ADPPK Implementation Guide

Hosted by the PKPD Programming subgroup of the Statistics and Pharmacometrics SIG for ASA and ISoP
sxpsig.github.io/
Speakers: Neelima Thanneer (BMS), Fang Li (FDA), Luke Reinbolt (Navitas)
Presentation slides and ADPPK Implementation Guide are posted here: sxpsig.github.io/events/paste...
This Webinar provides an overview of the work done by the ADaM sub-team (ADPPK), to build a CDISC ADaM standard for data supporting Population PK (PopPK) analysis, while accounting for use within a broad number of software packages. The associated software packages typically impose strict constraints on input data format, and common analysis data conventions in the expert community tend to make limited use of ADaM standards. We will describe the BDS-like implementation used for the PopPK standard and discuss the how we managed the differences between CDISC standards and analysis needs in this specialized area. It will highlight the advantages of implementing the ADaM ADPPK standards for improving quality, efficiency and collaboration across the industry. Webinar will also include FDA’s perspective in adopting these standards.
Original presentation: Friday, January 19, 2024, 12:00 - 1:00 pm EST