eamdacademy.org-p3UM-1789518388-o116172704 1789518388 Eurasian Academy of Medicine and Dentistry info@eamdacademy.org Eurasian Academy of Medicine and Dentistry Journal of Applied Pharmaceutical Technologies and Systems J Appl Pharm Technol Syst 3149-9589 2024 3 1 Maria Hernandez Carlos Vega 2024 10.68159/o116172704 https://eamdacademy.org/pub/journal/3/article/o116172704 Sun D, Gao W, Hu H, Zhou S. Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022;12(7):3049-62. Ioannidis JP, Kim BY, Trounson A. How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation. Nat Biomed Eng. 2018;2(11):797-809. Anselmo AC, Mitragotri S. Nanoparticles in the clinic: An update. Bioeng Transl Med. 2019;4(3):e10143. Hua S, De Matos MB, Metselaar JM, Storm G. Current trends and challenges in the clinical translation of nanoparticulate nanomedicines: pathways for translational development and commercialization. Front Pharmacol. 2018;9:790. Pagani E, Ropke CD, Soares CM, Perez SA, Benevides PJ, Barbosa BS, et al. Technology readiness level roadmap for developing innovative herbal medicinal products. Pharmaceuticals (Basel). 2024;17(6):703. Kedia SB, Baker JC, Carbonell RG, Lee KH, Roberts CJ, Erickson J, et al. Biomanufacturing readiness levels (BRL): A shared vocabulary for biopharmaceutical technology development and commercialization. Biotechnol Bioeng. 2022;119(12):3526-36. Younis MA, Tawfeek HM, Abdellatif AA, Abdel-Aleem JA, Harashima H. Clinical translation of nanomedicines: Challenges, opportunities, and keys. Adv Drug Deliv Rev. 2022;181:114083. Arnouts S, Brown S, De Arriba ML, Donabedian M, Charlier J. Technology readiness levels for vaccine and drug development in animal health: From discovery to life cycle management. Front Vet Sci. 2022;9:1016959. Salvador-Carulla L, Woods C, De Miquel C, Lukersmith S. Adaptation of the technology readiness levels for impact assessment in implementation sciences: The TRL-IS checklist. Heliyon. 2024;10(9):e30790. McGowran E, Harris E. Regulatory readiness level: A tool to enhance early regulatory adoption in academic discovery. Level 3. 2020;15(2):6. Vargason AM, Anselmo AC, Mitragotri S. The evolution of commercial drug delivery technologies. Nat Biomed Eng. 2021;5(9):951-67. Webster A, Gardner J. Aligning technology and institutional readiness: the adoption of innovation. Technol Anal Strateg Manag. 2019;31(10):1229-41. Tenchov R, Bird R, Curtze AE, Zhou Q. Lipid nanoparticles—from liposomes to mRNA vaccine delivery, a landscape of research diversity and advancement. ACS Nano. 2021;15(11):16982-7015. Hou X, Zaks T, Langer R, Dong Y. Lipid nanoparticles for mRNA delivery. Nat Rev Mater. 2021;6(12):1078-94. Joyce P, Allen CJ, Alonso MJ, Ashford M, Bradbury MS, Germain M, et al. A translational framework to DELIVER nanomedicines to the clinic. Nat Nanotechnol. 2024;19(11):1597-611. Đorđević S, Gonzalez MM, Conejos-Sánchez I, Carreira B, Pozzi S, Acúrcio RC, et al. Current hurdles to the translation of nanomedicines from bench to the clinic. Drug Deliv Transl Res. 2022;12(3):500-25. Duarah S, Sharma M, Wen J. Recent advances in microneedle-based drug delivery: Special emphasis on its use in paediatric population. Eur J Pharm Biopharm. 2019;136:48-69. Schoenmaker L, Witzigmann D, Kulkarni JA, Verbeke R, Kersten G, Jiskoot W, et al. mRNA-lipid nanoparticle COVID-19 vaccines: Structure and stability. Int J Pharm. 2021;601:120586. Fornaguera C, García-Celma MJ. Personalized nanomedicine: a revolution at the nanoscale. J Pers Med. 2017;7(4):12. Danaei M, Dehghankhold M, Ataei S, Hasanzadeh Davarani F, Javanmard R, Dokhani A, et al. Impact of particle size and polydispersity index on the clinical applications of lipidic nanocarrier systems. Pharmaceutics. 2018;10(2):57. Liu Y, Yang G, Hui Y, Ranaweera S, Zhao CX. Microfluidic nanoparticles for drug delivery. Small. 2022;18(36):2106580. Mitchell MJ, Billingsley MM, Haley RM, Wechsler ME, Peppas NA, Langer R. Engineering precision nanoparticles for drug delivery. Nat Rev Drug Discov. 2021;20(2):101-24. Dasgupta A, Sofias AM, Kiessling F, Lammers T. Nanoparticle delivery to tumours: from EPR and ATR mechanisms to clinical impact. Nat Rev Bioeng. 2024;2(9):714-26. Khalifa MM. Safety of nanoparticles in medicine. In: Nanocarriers in neurodegenerative disorders. Boca Raton: CRC Press; 2024. p. 94-100. Accomasso L, Cristallini C, Giachino C. Risk assessment and risk minimization in nanomedicine: a need for predictive, alternative, and 3Rs strategies. Front Pharmacol. 2018;9:228. Csóka I, Ismail R, Jójárt-Laczkovich O, Pallagi E. Regulatory considerations, challenges and risk-based approach in nanomedicine development. Curr Med Chem. 2021;28(36):7461-76. Pignatello R, Matricardi P. Steering the Clinical Translation of Delivery Systems for Drugs and Health Products. Pharmaceutics. 2020;12(4):350. 10.3390/pharmaceutics12040350 Germain M, Caputo F, Metcalfe S, Tosi G, Spring K, Åslund AK, et al. Delivering the power of nanomedicine to patients today. J Control Release. 2020;326:164-71. Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA. 2020;323(9):844-53. Zhang H, Li S, Ma X. Transforming healthcare with nanomedicine: a SWOT analysis of drug delivery innovation. Drug Des Devel Ther. 2024;18:3499-521. Babu MR, Vishwas S, Khursheed R, Harish V, Sravani AB, Khan F, et al. Unravelling the role of microneedles in drug delivery: Principle, perspectives, and practices. Drug Deliv Transl Res. 2024;14(6):1393-431. Lammers T, Ferrari M. The success of nanomedicine. Nano Today. 2020;31:100853. Metselaar JM, Lammers T. Challenges in nanomedicine clinical translation. Drug Deliv Transl Res. 2020;10(3):721-5. Wang S, Cheng K, Chen K, Xu C, Ma P, Dang G, et al. Nanoparticle-based medicines in clinical cancer therapy. Nano Today. 2022;45:101512. Anselmo AC, Gokarn Y, Mitragotri S. Non-invasive delivery strategies for biologics. Nat Rev Drug Discov. 2019;18(1):19-40.