Quality-by-Design Toolkit for Plant-Derived Excipients in Injectable Nanomedicines

This project archives the final, prospectively validated Quality-by-Design (QbD) Toolkit for plant-derived excipients (soy lecithin, chitosan, hyaluronic acid) in injectable nanomedicines. It includes: (1) a PRISMA-2020/GRADE-compliant systematic review and meta-analysis (156 studies); (2) validated design-space models (R² > 0.87) linking excipient attributes to critical quality attributes; (3) AI-enhanced Python/R control scripts for real-time PAT and machine learning–based prediction of pharmacokinetic outcomes; and (4) prospectively validated data from irinotecan liposome batches (n=3). All materials are aligned with ICH Q8–Q10 and designed for regulatory submission under FDA/EMA frameworks.