PumasCP End-to-End is a four-part series that follows a clinical pharmacology analysis through its full life cycle in a single reproducible environment — from raw concentrations to a submission-ready PK report. Each session pairs a hands-on demo with an Agent Spotlight. Attendees will leave understanding how a complete PK analysis flows through one reproducible environment, and also how an AI agent can accelerate each stage.

Target audience

Primary:

• Clinical pharmacologists and PK/PD scientists running or reviewing NCA, BE, dose-proportionality, and superposition analyses
• Pharmacometricians and quantitative clin-pharm scientists evaluating their tooling stack
• Regulatory and submission-facing scientists responsible for CSR appendices, TFLs, and CDISC deliverables (ADNCA/ADPC/ADPP)

Secondary:

• Biostatisticians supporting clinical pharmacology, pharmacometrics grad students/postdocs, and CRO/biotech teams evaluating platforms

Register here!

PumasCP End-to-End: From Raw Data to Regulatory-Ready PK Reporting

Session A: 2 Sep

Getting Started with PumasCP: Platform Tour & Building Analysis-Ready Datasets

Session A introduces the PumasCP platform and the philosophy behind a single, reproducible environment. We tour the interface and project structure, then focus on the foundation of every NCA: data wrangling and constructing an analysis-ready ADNCA dataset aligned with CDISC expectations.

Attendees will be able to:

• Navigate PumasCP and understand how projects, data, and outputs fit together
• Perform common wrangling steps (reshaping, joining dose/sampling records, BLQ and missing handling, nominal vs actual times)
• Assemble an ADNCA dataset

Topics/sub-topics

• Platform tour and project setup
• Data import and inspection
• Wrangling: reshaping, merging dose/concentration data, BLQ and missing handling, nominal vs actual times
• ADNCA construction; relationship to the broader CDISC dataset family
• Reconciling orphan samples and time deviations
• Agent Spotlight: agent-driven data wrangling

Session B: 9 Sep

From Concentrations to Conclusions: NCA, BE, Dose Proportionality & Superposition

Session B is the analytical core. We run an NCA (parameter estimation, λz selection, partial AUCs), then move into bioequivalence (log-transformed ANOVA, 90% CI against 80–125%, and HVD considerations), dose proportionality, and superposition for accumulation prediction — and show how to templatize each workflow for reuse across studies.

Attendees will be able to:

• Run an NCA, including λz/terminal-phase selection and partial AUCs
• Set up an average BE assessment and read the result against acceptance limits
• Assess dose proportionality
• Apply superposition to anticipate steady-state behavior
• Build reusable analysis templates to standardize and rerun work across studies

Topics/sub-topics

• NCA: parameters, λz selection, partial AUCs, exclusion/flagging semantics
• BE: ANOVA on log-transformed data, within-subject CV, T/R GMR, 90% CI; ABE vs RSABE for HVDs and replicate designs
• Dose proportionality (power-model approach)
• Superposition and accumulation prediction
• Templatizing tasks for reuse and consistency
• Agent Spotlight: agent-driven analysis setup

Session C: 16 Sep

Publication-Quality PK Graphics: Plotting from scratch or using Templates

Session C is about making figures excellent and reproducible. We start with PumasCP's publication-quality plot templates for standard PK outputs, then build a figure from scratch with the power of AlgebraOfGraphics.jl so you can customize without limits.

Attendees will be able to:

• Produce standard PK figures quickly using built-in publication-quality templates
• Build a custom figure from scratch
• Control layering, faceting, scales (including semi-log), and styling for journal- or submission-ready output
• Judge when to use a template versus build from scratch

Topics/sub-topics

• Built-in publication-quality templates (concentration–time, mean profiles, individual overlays, linear vs semi-log, box plots)
• AlgebraOfGraphics.jl fundamentals: data, mappings, layers, visual transforms
• Building a custom PK figure step by step
• Faceting, scales, theming, and export
• Template vs from-scratch: when to use which
• Agent Spotlight: agent-generated plotting

Session D: 23 Sep

Drafting the PK CSR in PumasCP: Reproducible Reporting, End-to-End Agent mode in PumasCP will also be showcased simultaneously.

Bringing it together — drafting a PK CSR entirely within PumasCP. We assemble tables, figures, and listings, weave them into report narrative, and produce traceable, submission-oriented output, touching on where structure intersects with eCTD expectations.

Attendees will be able to:

• Assemble TFLs and integrate them into a structured PK report in-platform
• Draft CSR narrative alongside results without exporting to a separate tool
• Produce reproducible, traceable reporting output suitable for review
• Understand how report sections map to expected CSR/eCTD structure
• Across all sessions, attendees see how the agent can accelerate the stage being covered.

Topics/sub-topics

• From analysis outputs to tables, figures, and listings
• Authoring report narrative in-platform
• Reproducibility and traceability from data → output → document
• Alignment with CSR structure and submission expectations (eCTD module placement at a high level)
• Assembling the full PK report
• Agent Spotlight: agent-assisted report drafting

Register here!