PK/PDレポートを効率化：表・図・リスト作成のスマートな新提案

Regulatory guidelines like ICH E3 lay out clear expectations for how data should be reported in clinical and nonclinical study documents. Agencies such as the FDA and EMA require:

• Clear labeling of datasets (e.g., PK analysis set vs. safety population)
• Documentation of deviations and exclusions
• Detailed listings of individual patient data
• Reproducible, traceable outputs
• Use of validated tools compliant with standards like 21 CFR Part 11

In practice, this means TFLs must not only look polished but also be auditable and consistent – requirements that can be challenging to meet using spreadsheets or loosely coordinated scripting workflows.

Excel is familiar and flexible, but it’s not built for complex PK/PD reporting. Manual formatting, formula errors, and lack of audit trails make it risky for regulatory work. Reproducing results or tracking changes across multiple versions is nearly impossible.

Statistical programming tools like SAS and R offer greater control and reproducibility, but they require significant coding expertise. For teams under time pressure—or without dedicated programmers – these tools can slow down the reporting process and add complexity.

TFL Studio is a new module in Certara’s Phoenix platform that combines the rigor of traditional programming with the ease of a modern user interface. Here’s how it stands out:

1. User-Friendly Workflow

With TFL Studio, scientists can create publication-ready tables and figures using customizable templates – no coding required. The point-and-click interface makes it easy to generate complex Tables, Figures and Listings in just a few steps, reducing reliance on programmers.

2. Template-Driven Automation

TFL Studio supports batch generation of TFLs from source data, allowing users to map data to templates without manual reformatting. Analysts can reuse custom-built tables and figures across studies, significantly accelerating the reporting timeline.

3. Built-In Traceability

Every transformation and setting applied in TFL Studio is stored as part of the output definition. An audit log tracks edits automatically, making it easy to demonstrate how outputs were created and to meet regulatory traceability standards.

One of the standout features of TFL Studio is its ability to streamline collaboration and quality control:

• Real-Time Review: Team members can review and comment on outputs directly within the platform – no more back-and-forth email threads or version confusion.
• Centralized QC: All feedback is logged in one place, ensuring corrections are applied consistently and transparently.
• Regulatory-Ready Outputs: TFL Studio adheres to global style standards, supports consistent footnotes, units, and titles, and integrates with Phoenix’s 21 CFR Part 11-compliant data repository Integral for added peace of mind.

For PK/PD teams navigating tight timelines, complex data, and evolving regulatory expectations, the stakes are high. TFL Studio offers:

• Speed: Automate routine work and focus on analysis.
• Accuracy: Minimize errors through traceable, standardized workflows.
• Collaboration: Work seamlessly across teams and roles.
• Compliance: Meet global regulatory standards with built-in audit capabilities.

Discover how TFL Studio and AI PK Reports can help you work faster, smarter, and more accurately through AI-powered automation.

Tables, figures and Listings remain essential to regulatory success in drug development – but the way we produce them doesn’t have to stay stuck in the past. TFL Studio represents a step forward: combining usability, automation, and compliance in one powerful platform tailored to the needs of PK/PD professionals.

If you’re ready to modernize your reporting workflows, it’s time to explore what TFL Studio can do for your team.