薬物投与システムの翻訳に影響を与える要因:先進技術,生物学的障壁,規制上の課題に焦点を当てた
Mervat Balash1, Hamza Boucetta1, Wei He2
1School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China.
まとめ
薬物投与システム (DDS) を臨床実用化するには,重要な生物学的および非生物学的障害があります. これらの課題を克服することは 癌や複雑な病気の新たな治療法の開発の鍵です
科学分野:
- 生物医学工学
- ナノテクノロジー
- 医薬品科学
背景:
- 薬物投与システム (DDS) の臨床翻訳は,特にがんや複雑な疾患の治療の進歩にとって重要な課題です.
- 生物学的および非生物学的要因は,臨床環境でのDDSの成功した実施を妨げています.
研究 の 目的:
- DDSの臨床翻訳に影響を与える要因を批判的に検討する.
- DDSの性能とサイト選択性に影響を与える生物学的障壁 (免疫,生物適合性,腫瘍の微小環境) と非生物学的障壁 (製造,規制問題) を明らかにする.
- 臓器チップやAIなどの新興技術を強調し,臨床前試験とDDSの設計を改善します.
主な方法:
- 薬物投与システムに関する既存の研究の文献レビューと批判的分析.
- DDS翻訳に影響を与える生物学的および非生物学的障壁の概念的明確化.
- 新興技術とその潜在的な影響の特定と議論
主要な成果:
- 免疫反応,生物互換性,腫瘍の微小環境の相互作用を含む生物学的障壁は,DDSの性能と標的化に大きな影響を及ぼします.
- 非生物学的障壁には,製造業の拡大,さまざまな市場 (米国,EU,中国) の複雑な規制状況,早期の規制の必要性が含まれます.
- オルガン・オン・ア・チップや AIのような新興技術は 臨床前試験の精度を高め,DDSの設計を最適化するための有望な解決策を提供します.
結論:
- 生物学的および非生物学的障壁の両方に対処することは,DDSの臨床翻訳の成功に不可欠です.
- 戦略的な規制の相互作用と革新的な技術の採用は,DDSの開発と治療応用を加速するために不可欠です.
- このレビューは,現在の課題を克服し,治療におけるDDSの実践的な使用を促進するための展望を提供します.
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