Roadmap for Commercial Nanomedicine Development: Integrating Quality by Design Principles with Pharmaceutical Nanotechnology

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Review demonstrates QbD enhances product quality and efficiency in nanomedicine, suggesting better compliance with FDA standards.

MAIN FINDING: QbD introduces a systematic approach to enhance the quality of pharmaceutical nanotechnology.
KEY EVIDENCE: Application of QbD practices indicates improved efficiency and consistency in nanoliposome formulations.
APPROACH: Various QbD models, including factorial and Box-Behnken designs, were analyzed alongside mathematical optimization methods.
SIGNIFICANCE: Bridging laboratory work with regulatory frameworks, QbD can significantly accelerate the commercialization of nanomedicine.

Maheshwari et al. (2025) studied this question.

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