The Evolution and Future Directions of PBPK Modeling in FDA Regulatory Review
Yong Li; Henry Sun; Zuoli Zhang · 2025 · Pharmaceutics
WASTE classifies this as Negative / Null Result Report · AI classification, approximate
The study found no significant effect — useful as a negative control or null benchmark for your own design.
Abstract
Background: Physiologically based pharmacokinetic (PBPK) modeling is a mathematical approach that integrates human physiological parameters with drug-specific characteristics (including both active pharmaceutical ingredients and excipients), and it has emerged as one of the core technologies for optimizing the efficiency and reliability of drug development. Methods: This study synthesizes applications of PBPK models in FDA-approved drugs (2020–2024), systematically analyzing model utilization frequency, indication distribution, application domains and choice of modeling platforms, to reveal th
Abstract by Yong Li; Henry Sun; Zuoli Zhang, Pharmaceutics (2025) — licensed CC BY 4.0.
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Metadata source: OpenAlex · DOI 10.3390/pharmaceutics17111413