Working towards a standardized population PK/PD reporting template for the industry

In the pharmaceutical industry, population PK/PD reports are a crucial component of regulatory submissions for drug approval. However, the lack of a standardized reporting template has led to significant variability in the style and format of population PK/PD reports. This variability is due to pharmaceutical and consulting companies using their own in-house templates, primarily for historical reasons. There have been significant developments in tools for report generation, which has yet to be widely adopted across the industry. Variability in reports adds burden to reviewers and impacts efficiency of pharmacometricians. To address this issue, an ISoP Standards and Best Practices working group has been established with a focus on creating a standardized population PK/PD report template that can be applied within the field.
This presentation will provide the pharmacometrics community with an update on progress towards a template that will satisfy regulatory requirements across the board (including FDA, EMA and PMDA). The audience will gain an understanding of the sections and format that should be consistent for all reports and will also be able to provide suggestions/input. The presentation will include aspects towards automated report writing, which is another benefit of a standardized report template. At a high level, the audience will be introduced to various approaches that could be implemented towards automated generation of reports of different complexities/length (e.g. a full report for a submission vs a brief report for an exploratory analysis).