PBPK FAQs

Question 1

What are NGRA-ready PBPK objects and how does the tool support NGRA workflows?

Accepted Answer

PBPK exports NGRA-ready objects containing assessment context, uncertainty summaries, and Point of Departure (PoD) references. It provides explicit boundary statements, workflow role declarations, and curation feedback for Non-Genotoxic Risk Assessment (NGRA), ensuring robust and transparent exposure-led risk evaluations.

Question 2

What is the PBPK tool designed for?

Accepted Answer

The PBPK tool is a server designed to manage physiologically based pharmacokinetic (PBPK) modeling workflows. It provides a unified, programmable interface for simulating, qualifying, and exporting PBPK models, simplifying complex pharmacokinetic studies and making them automatable and inspectable.

Question 3

What types of PBPK models and backends does it support?

Accepted Answer

PBPK offers dual-backend execution for both .pkml models (compatible with OSPSuite like PK-Sim/MoBi) and MCP-ready .R models (for rxode2). It also handles conversions from .pksim5 and .mmd inputs, providing flexibility for various mechanistic modeling approaches.

Question 4

How does PBPK ensure model qualification and regulatory compliance?

Accepted Answer

PBPK implements OECD-oriented qualification, meticulously tracking model capabilities, scientific profile, validation status, and overall qualification state. It performs executable verification checks, offers static manifest validation for NGRA gaps, and ships with regulatory benchmark comparisons to aid in achieving regulatory-grade use and audit evidence.

PBPK

PBPK

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主な機能

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