Review
BibTex RIS Cite

FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI

Year 2023, , 1058 - 1070, 20.09.2023
https://doi.org/10.33483/jfpau.1225743

Abstract

Amaç: Bu derlemede, teknolojideki gelişmelerin farmasötik endüstri bakış açısı ile değerlendirilmesi ve gelişen teknoloji ile ortaya çıkan Farma 4.0 yaklaşımının farmasötik üretim ve Ar-Ge alanlarına etkisinin tartışılması amaçlanmıştır.
Sonuç ve Tartışma: Farmasötik endüstri, teknolojik gelişmelerin öncelikle uygulandığı en önemli endüstri alanlarından biridir. Bununla birlikte, kaliteli, etkili ve güvenli ilaç üretme gerekliliği çoğu zaman farmasötik endüstrinin teknolojik gelişmeleri eş zamanlı takibi açısından kısıtlayıcı bir etken olarak görülmüştür. İlaç üretiminde konvansiyonel sistemlerin kullanılması ile yaşanan zorluklar, ilaç üreticilerini kaçınılmaz olarak ve teknolojik gelişmeler doğrultusunda verimli alternatifler aramaya yöneltmiştir. Endüstri 4.0 kavramının ortaya çıkması ile bu yaklaşımın farmasötik endüstrideki uygulanabilirliği tartışılmaya başlanmıştır. Yapay zeka, nesnelerin interneti, makine öğrenimi ve bulut sistemler, Endüstri 4.0’ın temel bileşenlerini oluşturmaktadır. Veri ve deney tasarımlarının oldukça önemli olduğu ilaç keşfi ve formülasyon geliştirme alanlarında bu bileşenlerin kullanımı verimlilik, etkililik ve güvenlik açısından büyük bir potansiyele sahiptir. Endüstri 4.0 kavramının farmasötik alandaki karşılığı olarak tanımlanan Farma 4.0, verimliliği artırmasının yanında çevreci üretim sistemleri kurmayı da vadeden ve böylece sürdürülebilirliği destekleyen bir yaklaşımdır. Yeni endüstri devrimi ile tüm dünyanın büyük bir dönüşüm içerisine girdiği teknoloji çağında, farmasötik endüstrinin de bu gelişmelere en kısa sürede uyum sağlaması gerekmektedir.

References

  • 1. Suleiman, Z., Shaikholla, S., Dikhanbayeva, D., Shehab, E., Turkyilmaz, A. (2022). Industry 4.0: Clustering of concepts and characteristics. Cogent Engineering, 9(1), 2034264. [CrossRef]
  • 2. Pharma 4.0TM: Hype or Reality? (2018, July 1). Erişim adresi https://ispe.org/pharmaceutical-engineering/july-august-2018/pharma-40tm-hype-or-reality Erişim tarihi: 01.10.2022.
  • 3. Burritt, R., Christ, K. (2016). Industry 4.0 and environmental accounting: a new revolution? Asian Journal of Sustainability and Social Responsibility, 1(1), 23-38. [CrossRef]
  • 4. Stearns, P. N. (2020). The industrial revolution in world history. Routledge. p.19.
  • 5. Arden, N.S., Fisher, A.C., Tyner, K., Lawrence, X.Y., Lee, S.L., Kopcha, M. (2021). Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future. International Journal of Pharmaceutics, 602, 120554. [CrossRef]
  • 6. Anderson, S. (2005). Making Medicines: A Brief History of Pharmacy and Pharmaceuticals, London, p.37.
  • 7. Groumpos, P.P. (2021). A critical historical and scientific overview of all industrial revolutions. IFAC-PapersOnLine, 54(13), 464-471. [CrossRef]
  • 8. Quality: Quality by Design (QbD) - European Medicines Agency. (2018, September 17). Erişim adresi: https://www.ema.europa.eu/en/humanregulatory/researchdevelopment/scientificguidelines/ quality/quality-quality-design-qbd#guidelines section. Erişim Tarihi: 01.10.202.
  • 9. PAT-A Framework for Innovative Pharmaceutical Development, Manufac. (2018, August 24). Erişim adresi https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance. Erişim Tarihi: 01.10.2022.
  • 10. ICH Q8 (R2) Pharmaceutical development - European Medicines Agency. (2018, September 17). Erişim adresi https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development. Erişim Tarihi: 01.10.2022.
  • 11. Zhou, K., Liu, T., Zhou, L. (2015, August). Industry 4.0: Towards future industrial opportunities and challenges. In 2015 12th International conference on fuzzy systems and knowledge discovery (FSKD) (pp. 2147-2152). IEEE. [CrossRef]
  • 12. Nair, M. M., Tyagi, A. K., Sreenath, N. (2021, January). The future with industry 4.0 at the core of society 5.0: open issues, future opportunities and challenges. In 2021 International Conference on Computer Communication and Informatics (ICCCI) (pp. 1-7). IEEE. [CrossRef]
  • 13. Pamuk, N.S., Soysal, M. (2018). Yeni sanayi devrimi endüstri 4.0 üzerine bir inceleme. Verimlilik Dergisi, (1), 41-66. from https://dergipark.org.tr/tr/pub/verimlilik/issue/34982/388198. Erişim tarihi: 01.10.2022.
  • 14. Zakoldaev, D.A., Shukalov, A.V., Zharinov, I.O. (2019, June). From Industry 3.0 to Industry 4.0: production modernization and creation of innovative digital companies. In IOP Conference Series: Materials Science and Engineering (Vol. 560, No. 1, p. 012206). IOP Publishing. [CrossRef]
  • 15. Mike, F., Pehlivan, S.B., Öner, L. (2013). Farmasötik ürünlerde tasarımla kalite yaklaşımı. Hacettepe University Journal of the Faculty of Pharmacy, (2), 203-230.
  • 16. Pramod, K., Tahir, M.A., Charoo, N.A., Ansari, S.H., Ali, J. (2016). Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation, 6(3), 129. [CrossRef]
  • 17. Garcia, T., Cook, G., Nosal, R. (2008). PQLI key topics-criticality, design space, and control strategy. Journal of Pharmaceutical Innovation, 3(2), 60-68. [CrossRef]
  • 18. ICH Q9 Quality risk management - European Medicines Agency. (2015, September 1). Erişim adresi https://www.ema.europa.eu/en/ich-q9-quality-risk-management Erişim Tarihi: 01.10.2022.
  • 19. Lee, S.L., O’Connor, T.F., Yang, X., Cruz, C.N., Chatterjee, S., Madurawe, R.D., Woodcock, J. (2015). Modernizing pharmaceutical manufacturing: From batch to continuous production. Journal of Pharmaceutical Innovation, 10(3), 191-199. [CrossRef]
  • 20. Allison, G., Cain, Y.T., Cooney, C., Garcia, T., Bizjak, T.G., Holte, O., Jagota, N., Komas, B., Korakianiti, E., Kourti, D., Madurawe, R., Morefield, E., Montgomery, F., Nasr, M., Randolf, W., Robert, J.L., Rudd, D., Zezza, D. (2015). Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 continuous manufacturing symposium. Journal of Pharmaceutical Sciences, 104(3), 803-812. [CrossRef]
  • 21. Bioprocess monitoring and control (off-line, at-line, on-line, in-line / in-situ). Erişim adresi https://www.hamiltoncompany.com/process-analytics/process-analytical-technology/bioprocess-monitoring-and-control. Erişim Tarihi: 01.10.2022.
  • 22. Biechele, P., Busse, C., Solle, D., Scheper, T., Reardon, K. (2015). Sensor systems for bioprocess monitoring. Engineering in Life Sciences, 15(5), 469-488. [CrossRef]
  • 23. Shek, C.F., Betenbaugh, M. (2021). Taking the pulse of bioprocesses: At-line and in-line monitoring of mammalian cell cultures. Current Opinion in Biotechnology, 71, 191-197. [CrossRef]
  • 24. Jiang, M., Severson, K.A., Love, J.C., Madden, H., Swann, P., Zang, L., Braatz, R.D. (2017). Opportunities and challenges of real‐time release testing in biopharmaceutical manufacturing. Biotechnology and Bioengineering, 114(11), 2445-2456. [CrossRef]
  • 25. Real time release testing - European Medicines Agency. (2014, April 13). Erişim adresi https://www.ema.europa.eu/en/real-time-release-testing. Erişim Tarihi: 01.10.2022.
  • 26. Teja, T.B., Sekar, M., Pallavi, T., Mettu, S., Murthy, T.E.G., Mat Rani, N.N.I., Bramhachari, P.V., Bonam, S.R. (2022). Role of artificial neural networks in pharmaceutical sciences. Journal of Young Pharmacists, 14(1), 6-14. [CrossRef]
  • 27. Agatonovic-Kustrin, S., Beresford, R. (2000). Basic concepts of artificial neural network (ANN) modeling and its application in pharmaceutical research. Journal of Pharmaceutical and Biomedical Analysis, 22(5), 717-727. [CrossRef]
  • 28. Aktas, E., Eroglu, H., Kockan, U., Oner, L. (2013). Systematic development of pH-independent controlled release tablets of carvedilol using central composite design and artificial neural networks. Drug Development and Industrial Pharmacy, 39(8), 1207-1216. [CrossRef]
  • 29. Güler, G.K., Eroğlu, H., Öner, L. (2017). Development and formulation of floating tablet formulation containing rosiglitazone maleate using artificial neural network. Journal of Drug Delivery Science and Technology, 39, 385-397. [CrossRef]
  • 30. Kesavan, J.G., Peck, G.E. (1996). Pharmaceutical granulation and tablet formulation using neural networks. Pharmaceutical Development and Technology, 1(4), 391-404. [CrossRef]
  • 31. Ibrić, S., Djuriš, J., Parojčić, J., Djurić, Z. (2012). Artificial neural networks in evaluation and optimization of modified release solid dosage forms. Pharmaceutics, 4(4), 531-550. [CrossRef]
  • 32. Leane, M.M., Cumming, I., Corrigan, O.I. (2003). The use of artificial neural networks for the selection of the most appropriate formulation and processing variables in order to predict the in vitro dissolution of sustained release minitablets. AAPS Pharmscitech, 4(2), 129-140. [CrossRef]
  • 33. Barenji, R.V., Akdag, Y., Yet, B., Oner, L. (2019). Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0. International Journal of Pharmaceutics, 567, 118445. [CrossRef]
  • 34. Kumar, S.H., Talasila, D., Gowrav, M.P., Gangadharappa, H.V. (2020). Adaptations of Pharma 4.0 from Industry 4.0. Drug Invention Today, 14(3).
  • 35. Pharma 4.0 Operating Model | Industry 4.0 | ISPE | International Society for Pharmaceutical Engineering. (2021, October 21). Erişim adresi https://ispe.org/initiatives/pharma-4.0 Erişim Tarihi: 05.10.2022.
  • 36. Henstock, P.V. (2019). Artificial intelligence for pharma: Time for internal investment. Trends in Pharmacological Sciences, 40(8), 543-546. [CrossRef]
  • 37. Devagiri, J.S., Paheding, S., Niyaz, Q., Yang, X., Smith, S. (2022). Augmented reality and artificial intelligence in industry: Trends, tools, and future challenges. Expert Systems with Applications, 207, 118002. [CrossRef]
  • 38. 43 Pharma Companies Using Artificial Intelligence in Drug Discovery. Erişim adresi https://blog.benchsci.com/pharma-companies-using-artificial-intelligence-in-drug-discovery. Erişim Tarihi: 05.10.2022.
  • 39. AiCure announces new study results demonstrating 90% adherence from Phase 2 Abbvie Study - Medication Adherence in Clinical Trials with Patient-Level AI. (2016, September 26). Erişim adresi https://aicure.com/news/aicure-announces-new-study-results-demonstrating-90-adherence-phase-2-abbvie-study/. Erişim Tarihi: 05.10.2022.
  • 40. AstraZeneca starts artificial intelligence collaboration to accelerate. Erişim adresi: https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-starts-artificial-intelligence-collaboration-to-accelerate-drug-discovery-30042019.html. Erişim Tarihi: 05.10.2022.
  • 41. Pfizer launches new collaboration with XTALPI for AI Drug Modeling. Erişim adresi https://www.fiercebiotech.com/cro/pfizer-launches-new-collaboration-xtalpi-for-ai-drug-modeling. Erişim Tarihi: 05.10.2022.
  • 42. Bannigan, P., Aldeghi, M., Bao, Z., Häse, F., Aspuru-Guzik, A., Allen, C. (2021). Machine learning directed drug formulation development. Advanced Drug Delivery Reviews, 175, 113806. [CrossRef]
  • 43. Han, R., Xiong, H., Ye, Z., Yang, Y., Huang, T., Jing, Q., Lu, J., Pan, H., Ren, F., Ouyang, D. (2019). Predicting physical stability of solid dispersions by machine learning techniques. Journal of Controlled Release, 311, 16-25. [CrossRef]
  • 44. What Is Big Data? How Does Big Data Work? | Built In. (2022, September 15). Erişim adresi https://builtin.com/big-data. Erişim Tarihi: 08.10.2022.
  • 45. European Medicines Agency. Big Data. Erişim adresi https://www.ema.europa.eu/en/about-us/how-we-work/big-data. Erişim Tarihi: 11.03.2023.
  • 46. Sultan, N. (2014). Making use of cloud computing for healthcare provision: Opportunities and challenges. International Journal of Information Management, 34(2), 177-184. [CrossRef]
  • 47. Pfizer. (2018, May 8). AWS Helps Pfizer Accelerate Drug Development and Clinical Research. Pfizer. Erişim adresi https://www.pfizer.com/news/press-release/press-release-detail/aws-helps-pfizer-accelerate-drug-development-and-clinical-research. Erişim Tarihi: 11.03.2023.
  • 48. GE Healthcare. (2021). Enterprise Imaging in the Cloud: Overcoming Challenges and Increasing ROI. GE Healthcare. Erişim adresi https://www.gehealthcare.com/insights/article/enterprise-imaging-in-the-cloud-overcoming-challenges-and-increasing-roi. Erişim Tarihi: 11.03.2023.
  • 49. Sharma, A., Singh, A., Gupta, V., Arya, S. (2022). Advancements and future prospects of wearable sensing technology for healthcare applications. Sensors & Diagnostics, 1(3), 387-404. [CrossRef]
  • 50. Razdan, S., Sharma, S. (2022). Internet of Medical Things (IoMT): Overview, emerging technologies, and case studies. IETE Technical Review, 39, 775-788. [CrossRef]
  • 51. Gia, T.N., Ali, M., Dhaou, I.B., Rahmani, A.M., Westerlund, T., Liljeberg, P., Tenhunen, H. (2017). IoT-based continuous glucose monitoring system: A feasibility study. Procedia Computer Science, 109, 327-334. [CrossRef]
  • 52. Wearable Heart Rhythm Monitors: Which One, When, and Why? (2019, February 18). Erişim adresi https://thedoctorweighsin.com/wearable-heart-rhythm-monitors/. Erişim Tarihi: 08.10.2022.
  • 53. The Mood-Aware Internet of Things. (2015, July 24). Erişim adresi https://blog.affectiva.com/the-mood-aware-internet-of-things. Erişim Tarihi: 08.10.2022.
  • 54. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. (2017, November 13). Erişim adresi https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication. Erişim Tarihi: 08.10.2022.
  • 55. How the ABILIFY MYCITE® System Works - ABILIFY MYCITE® System. Erişim adresi https://www.abilifymycite.com/how-mycite-works. Erişim Tarihi: 08.10.2022.
  • 56. DiCarlo, L., Moon, G., Intondi, A., Duck, R., Frank, J., Hafazi, H., Behzadi, Y., Robertson, T., Costello, B., Savage G., Zdeblick, M. (2012). A digital health solution for using and managing medications: Wirelessly observed therapy. IEEE pulse, 3(5), 23-26. [CrossRef]
  • 57. Sharma, A., Kaur, J., Singh, I. (2020). Internet of things (IoT) in pharmaceutical manufacturing, warehousing, and supply chain management. SN Computer Science, 1(4), 232. [CrossRef]
  • 58. Ghobakhloo, M. (2020). Industry 4.0, digitization, and opportunities for sustainability. Journal of Cleaner Production, 252, 119869. [CrossRef]
  • 59. Glavič, P., Lukman, R. (2007). Review of sustainability terms and their definitions. Journal of Cleaner Production, 15(18), 1875-1885. [CrossRef]
  • 60. Sorumlu Üretim ve Tüketim | Kuresel Amaçlar. Erişim adresi https://www.kureselamaclar.org /amaclar/sorumlu-uretim-ve-tuketim/. Erişim Tarihi: 08.10.2022.
  • 61. Industry 5.0. (2022, January 10). Erişim adresi https://research-and-innovation.ec.europa.eu/research-area/industry/industry-50_en. Erişim Tarihi: 08.10.2022.
  • 62. Aleksić, I. (2021). Green pharmaceutical manufacturing: Approaches and perspectives. Archives of Pharmacy, 71(Suppl. 5), s14.
  • 63. Becker, K., Salar-Behzadi, S., Zimmer, A. (2015). Solvent-free melting techniques for the preparation of lipid-based solid oral formulations. Pharmaceutical Research, 32(5), 1519-1545. [CrossRef]
  • 64. Bose, S., Bogner, R.H. (2007). Solventless pharmaceutical coating processes: A review. Pharmaceutical Development and Technology, 12(2), 115-131. [CrossRef]
  • 65. Belkhir, L., Elmeligi, A. (2019). Carbon footprint of the global pharmaceutical industry and relative impact of its major players. Journal of Cleaner Production, 214, 185-194. [CrossRef]
  • 66. Ford, S., Despeisse, M. (2016). Additive manufacturing and sustainability: an exploratory study of the advantages and challenges. Journal of Cleaner Production, 137, 1573-1587. [CrossRef]
  • 67. Jin, M., Tang, R., Ji, Y., Liu, F., Gao, L., Huisingh, D. (2017). Impact of advanced manufacturing on sustainability: An overview of the special volume on advanced manufacturing for sustainability and low fossil carbon emissions. Journal of Cleaner Production, 161, 69-74. [CrossRef]
  • 68. Beier, G., Niehoff, S., Ziems, T., Xue, B. (2017). Sustainability aspects of a digitalized industry-A comparative study from China and Germany. International Journal of Precision Engineering and Manufacturing-Green Technology, 4(2), 227-234. [CrossRef]
  • 69. Winkle, H.N., Nasr, M.M. (2011, September 2). FDA Perspectives: Understanding Challenges to Quality by Design. Erişim adresi https://www.pharmtech.com/view/fda-perspectives-understanding challenges-quality-design. Erişim Tarihi: 20.11.2022.
  • 70. Lou, H., Lian, B., Hageman, M.J. (2021). Applications of machine learning in solid oral dosage form development. Journal of Pharmaceutical Sciences, 110(9), 3150-3165. [CrossRef]
  • 71. Caudai, C., Galizia, A., Geraci, F., Le Pera, L., Morea, V., Salerno, E., Via, A., Colombo, T. (2021). AI applications in functional genomics. Computational and Structural Biotechnology Journal, 19, 5762-5790. [CrossRef]
  • 72. Schmidt, A., Frey, J., Hillen, D., Horbelt, J., Schandar, M., Schneider, D., Sorokos, I. (2021). A framework for automated quality assurance and documentation for pharma 4.0. In International Conference on Computer Safety, Reliability and Security (pp. 226-239). Springer, Cham. [CrossRef]
  • 73. Manogaran, G., Thota, C., Lopez, D., Sundarasekar, R. (2017). Big data security intelligence for healthcare industry 4.0. In Cybersecurity for Industry 4.0 (pp. 103-126). Springer, Cham. [CrossRef]
  • 74. Vrchota, J., Pech, M., Rolínek, L., Bednář, J. (2020). Sustainability outcomes of green processes in relation to industry 4.0 in manufacturing: Systematic review. Sustainability, 12(15), 5968. [CrossRef]

PHARMA 4.0 APPROACH IN PHARMACEUTICAL INDUSTRY

Year 2023, , 1058 - 1070, 20.09.2023
https://doi.org/10.33483/jfpau.1225743

Abstract

Objective: The purpose of this review is to evaluate developments in technology from the perspective of the pharmaceutical industry and to discuss the impact of Pharma 4.0 approach, which emerged with developing technology, on pharmaceutical production and R&D areas.
Result and Discussion: Pharmaceutical industry is one of the important industrial areas. However, the need to produce quality, effective and safe products has often been seen as a limiting factor in the pharmaceutical industry's ability to keep pace with technological advances. With the emergence of Industry 4.0 concept, the applicability of this approach in the pharmaceutical industry has started to be discussed. The use of key components of Industry 4.0 in the pharmaceutical industry, where data and experimental designs are crucial, has great potential for efficiency, efficacy, and safety. Pharma 4.0, which is defined as the pharmaceutical equivalent of Industry 4.0, promises to establish environmentally friendly production systems as well as increase efficiency and thus support sustainability. In the age of technology, where the whole world is undergoing a major transformation with the new industrial revolution, the pharmaceutical industry needs to adapt to these developments as soon as possible.

References

  • 1. Suleiman, Z., Shaikholla, S., Dikhanbayeva, D., Shehab, E., Turkyilmaz, A. (2022). Industry 4.0: Clustering of concepts and characteristics. Cogent Engineering, 9(1), 2034264. [CrossRef]
  • 2. Pharma 4.0TM: Hype or Reality? (2018, July 1). Erişim adresi https://ispe.org/pharmaceutical-engineering/july-august-2018/pharma-40tm-hype-or-reality Erişim tarihi: 01.10.2022.
  • 3. Burritt, R., Christ, K. (2016). Industry 4.0 and environmental accounting: a new revolution? Asian Journal of Sustainability and Social Responsibility, 1(1), 23-38. [CrossRef]
  • 4. Stearns, P. N. (2020). The industrial revolution in world history. Routledge. p.19.
  • 5. Arden, N.S., Fisher, A.C., Tyner, K., Lawrence, X.Y., Lee, S.L., Kopcha, M. (2021). Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future. International Journal of Pharmaceutics, 602, 120554. [CrossRef]
  • 6. Anderson, S. (2005). Making Medicines: A Brief History of Pharmacy and Pharmaceuticals, London, p.37.
  • 7. Groumpos, P.P. (2021). A critical historical and scientific overview of all industrial revolutions. IFAC-PapersOnLine, 54(13), 464-471. [CrossRef]
  • 8. Quality: Quality by Design (QbD) - European Medicines Agency. (2018, September 17). Erişim adresi: https://www.ema.europa.eu/en/humanregulatory/researchdevelopment/scientificguidelines/ quality/quality-quality-design-qbd#guidelines section. Erişim Tarihi: 01.10.202.
  • 9. PAT-A Framework for Innovative Pharmaceutical Development, Manufac. (2018, August 24). Erişim adresi https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance. Erişim Tarihi: 01.10.2022.
  • 10. ICH Q8 (R2) Pharmaceutical development - European Medicines Agency. (2018, September 17). Erişim adresi https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development. Erişim Tarihi: 01.10.2022.
  • 11. Zhou, K., Liu, T., Zhou, L. (2015, August). Industry 4.0: Towards future industrial opportunities and challenges. In 2015 12th International conference on fuzzy systems and knowledge discovery (FSKD) (pp. 2147-2152). IEEE. [CrossRef]
  • 12. Nair, M. M., Tyagi, A. K., Sreenath, N. (2021, January). The future with industry 4.0 at the core of society 5.0: open issues, future opportunities and challenges. In 2021 International Conference on Computer Communication and Informatics (ICCCI) (pp. 1-7). IEEE. [CrossRef]
  • 13. Pamuk, N.S., Soysal, M. (2018). Yeni sanayi devrimi endüstri 4.0 üzerine bir inceleme. Verimlilik Dergisi, (1), 41-66. from https://dergipark.org.tr/tr/pub/verimlilik/issue/34982/388198. Erişim tarihi: 01.10.2022.
  • 14. Zakoldaev, D.A., Shukalov, A.V., Zharinov, I.O. (2019, June). From Industry 3.0 to Industry 4.0: production modernization and creation of innovative digital companies. In IOP Conference Series: Materials Science and Engineering (Vol. 560, No. 1, p. 012206). IOP Publishing. [CrossRef]
  • 15. Mike, F., Pehlivan, S.B., Öner, L. (2013). Farmasötik ürünlerde tasarımla kalite yaklaşımı. Hacettepe University Journal of the Faculty of Pharmacy, (2), 203-230.
  • 16. Pramod, K., Tahir, M.A., Charoo, N.A., Ansari, S.H., Ali, J. (2016). Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation, 6(3), 129. [CrossRef]
  • 17. Garcia, T., Cook, G., Nosal, R. (2008). PQLI key topics-criticality, design space, and control strategy. Journal of Pharmaceutical Innovation, 3(2), 60-68. [CrossRef]
  • 18. ICH Q9 Quality risk management - European Medicines Agency. (2015, September 1). Erişim adresi https://www.ema.europa.eu/en/ich-q9-quality-risk-management Erişim Tarihi: 01.10.2022.
  • 19. Lee, S.L., O’Connor, T.F., Yang, X., Cruz, C.N., Chatterjee, S., Madurawe, R.D., Woodcock, J. (2015). Modernizing pharmaceutical manufacturing: From batch to continuous production. Journal of Pharmaceutical Innovation, 10(3), 191-199. [CrossRef]
  • 20. Allison, G., Cain, Y.T., Cooney, C., Garcia, T., Bizjak, T.G., Holte, O., Jagota, N., Komas, B., Korakianiti, E., Kourti, D., Madurawe, R., Morefield, E., Montgomery, F., Nasr, M., Randolf, W., Robert, J.L., Rudd, D., Zezza, D. (2015). Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 continuous manufacturing symposium. Journal of Pharmaceutical Sciences, 104(3), 803-812. [CrossRef]
  • 21. Bioprocess monitoring and control (off-line, at-line, on-line, in-line / in-situ). Erişim adresi https://www.hamiltoncompany.com/process-analytics/process-analytical-technology/bioprocess-monitoring-and-control. Erişim Tarihi: 01.10.2022.
  • 22. Biechele, P., Busse, C., Solle, D., Scheper, T., Reardon, K. (2015). Sensor systems for bioprocess monitoring. Engineering in Life Sciences, 15(5), 469-488. [CrossRef]
  • 23. Shek, C.F., Betenbaugh, M. (2021). Taking the pulse of bioprocesses: At-line and in-line monitoring of mammalian cell cultures. Current Opinion in Biotechnology, 71, 191-197. [CrossRef]
  • 24. Jiang, M., Severson, K.A., Love, J.C., Madden, H., Swann, P., Zang, L., Braatz, R.D. (2017). Opportunities and challenges of real‐time release testing in biopharmaceutical manufacturing. Biotechnology and Bioengineering, 114(11), 2445-2456. [CrossRef]
  • 25. Real time release testing - European Medicines Agency. (2014, April 13). Erişim adresi https://www.ema.europa.eu/en/real-time-release-testing. Erişim Tarihi: 01.10.2022.
  • 26. Teja, T.B., Sekar, M., Pallavi, T., Mettu, S., Murthy, T.E.G., Mat Rani, N.N.I., Bramhachari, P.V., Bonam, S.R. (2022). Role of artificial neural networks in pharmaceutical sciences. Journal of Young Pharmacists, 14(1), 6-14. [CrossRef]
  • 27. Agatonovic-Kustrin, S., Beresford, R. (2000). Basic concepts of artificial neural network (ANN) modeling and its application in pharmaceutical research. Journal of Pharmaceutical and Biomedical Analysis, 22(5), 717-727. [CrossRef]
  • 28. Aktas, E., Eroglu, H., Kockan, U., Oner, L. (2013). Systematic development of pH-independent controlled release tablets of carvedilol using central composite design and artificial neural networks. Drug Development and Industrial Pharmacy, 39(8), 1207-1216. [CrossRef]
  • 29. Güler, G.K., Eroğlu, H., Öner, L. (2017). Development and formulation of floating tablet formulation containing rosiglitazone maleate using artificial neural network. Journal of Drug Delivery Science and Technology, 39, 385-397. [CrossRef]
  • 30. Kesavan, J.G., Peck, G.E. (1996). Pharmaceutical granulation and tablet formulation using neural networks. Pharmaceutical Development and Technology, 1(4), 391-404. [CrossRef]
  • 31. Ibrić, S., Djuriš, J., Parojčić, J., Djurić, Z. (2012). Artificial neural networks in evaluation and optimization of modified release solid dosage forms. Pharmaceutics, 4(4), 531-550. [CrossRef]
  • 32. Leane, M.M., Cumming, I., Corrigan, O.I. (2003). The use of artificial neural networks for the selection of the most appropriate formulation and processing variables in order to predict the in vitro dissolution of sustained release minitablets. AAPS Pharmscitech, 4(2), 129-140. [CrossRef]
  • 33. Barenji, R.V., Akdag, Y., Yet, B., Oner, L. (2019). Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0. International Journal of Pharmaceutics, 567, 118445. [CrossRef]
  • 34. Kumar, S.H., Talasila, D., Gowrav, M.P., Gangadharappa, H.V. (2020). Adaptations of Pharma 4.0 from Industry 4.0. Drug Invention Today, 14(3).
  • 35. Pharma 4.0 Operating Model | Industry 4.0 | ISPE | International Society for Pharmaceutical Engineering. (2021, October 21). Erişim adresi https://ispe.org/initiatives/pharma-4.0 Erişim Tarihi: 05.10.2022.
  • 36. Henstock, P.V. (2019). Artificial intelligence for pharma: Time for internal investment. Trends in Pharmacological Sciences, 40(8), 543-546. [CrossRef]
  • 37. Devagiri, J.S., Paheding, S., Niyaz, Q., Yang, X., Smith, S. (2022). Augmented reality and artificial intelligence in industry: Trends, tools, and future challenges. Expert Systems with Applications, 207, 118002. [CrossRef]
  • 38. 43 Pharma Companies Using Artificial Intelligence in Drug Discovery. Erişim adresi https://blog.benchsci.com/pharma-companies-using-artificial-intelligence-in-drug-discovery. Erişim Tarihi: 05.10.2022.
  • 39. AiCure announces new study results demonstrating 90% adherence from Phase 2 Abbvie Study - Medication Adherence in Clinical Trials with Patient-Level AI. (2016, September 26). Erişim adresi https://aicure.com/news/aicure-announces-new-study-results-demonstrating-90-adherence-phase-2-abbvie-study/. Erişim Tarihi: 05.10.2022.
  • 40. AstraZeneca starts artificial intelligence collaboration to accelerate. Erişim adresi: https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-starts-artificial-intelligence-collaboration-to-accelerate-drug-discovery-30042019.html. Erişim Tarihi: 05.10.2022.
  • 41. Pfizer launches new collaboration with XTALPI for AI Drug Modeling. Erişim adresi https://www.fiercebiotech.com/cro/pfizer-launches-new-collaboration-xtalpi-for-ai-drug-modeling. Erişim Tarihi: 05.10.2022.
  • 42. Bannigan, P., Aldeghi, M., Bao, Z., Häse, F., Aspuru-Guzik, A., Allen, C. (2021). Machine learning directed drug formulation development. Advanced Drug Delivery Reviews, 175, 113806. [CrossRef]
  • 43. Han, R., Xiong, H., Ye, Z., Yang, Y., Huang, T., Jing, Q., Lu, J., Pan, H., Ren, F., Ouyang, D. (2019). Predicting physical stability of solid dispersions by machine learning techniques. Journal of Controlled Release, 311, 16-25. [CrossRef]
  • 44. What Is Big Data? How Does Big Data Work? | Built In. (2022, September 15). Erişim adresi https://builtin.com/big-data. Erişim Tarihi: 08.10.2022.
  • 45. European Medicines Agency. Big Data. Erişim adresi https://www.ema.europa.eu/en/about-us/how-we-work/big-data. Erişim Tarihi: 11.03.2023.
  • 46. Sultan, N. (2014). Making use of cloud computing for healthcare provision: Opportunities and challenges. International Journal of Information Management, 34(2), 177-184. [CrossRef]
  • 47. Pfizer. (2018, May 8). AWS Helps Pfizer Accelerate Drug Development and Clinical Research. Pfizer. Erişim adresi https://www.pfizer.com/news/press-release/press-release-detail/aws-helps-pfizer-accelerate-drug-development-and-clinical-research. Erişim Tarihi: 11.03.2023.
  • 48. GE Healthcare. (2021). Enterprise Imaging in the Cloud: Overcoming Challenges and Increasing ROI. GE Healthcare. Erişim adresi https://www.gehealthcare.com/insights/article/enterprise-imaging-in-the-cloud-overcoming-challenges-and-increasing-roi. Erişim Tarihi: 11.03.2023.
  • 49. Sharma, A., Singh, A., Gupta, V., Arya, S. (2022). Advancements and future prospects of wearable sensing technology for healthcare applications. Sensors & Diagnostics, 1(3), 387-404. [CrossRef]
  • 50. Razdan, S., Sharma, S. (2022). Internet of Medical Things (IoMT): Overview, emerging technologies, and case studies. IETE Technical Review, 39, 775-788. [CrossRef]
  • 51. Gia, T.N., Ali, M., Dhaou, I.B., Rahmani, A.M., Westerlund, T., Liljeberg, P., Tenhunen, H. (2017). IoT-based continuous glucose monitoring system: A feasibility study. Procedia Computer Science, 109, 327-334. [CrossRef]
  • 52. Wearable Heart Rhythm Monitors: Which One, When, and Why? (2019, February 18). Erişim adresi https://thedoctorweighsin.com/wearable-heart-rhythm-monitors/. Erişim Tarihi: 08.10.2022.
  • 53. The Mood-Aware Internet of Things. (2015, July 24). Erişim adresi https://blog.affectiva.com/the-mood-aware-internet-of-things. Erişim Tarihi: 08.10.2022.
  • 54. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. (2017, November 13). Erişim adresi https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication. Erişim Tarihi: 08.10.2022.
  • 55. How the ABILIFY MYCITE® System Works - ABILIFY MYCITE® System. Erişim adresi https://www.abilifymycite.com/how-mycite-works. Erişim Tarihi: 08.10.2022.
  • 56. DiCarlo, L., Moon, G., Intondi, A., Duck, R., Frank, J., Hafazi, H., Behzadi, Y., Robertson, T., Costello, B., Savage G., Zdeblick, M. (2012). A digital health solution for using and managing medications: Wirelessly observed therapy. IEEE pulse, 3(5), 23-26. [CrossRef]
  • 57. Sharma, A., Kaur, J., Singh, I. (2020). Internet of things (IoT) in pharmaceutical manufacturing, warehousing, and supply chain management. SN Computer Science, 1(4), 232. [CrossRef]
  • 58. Ghobakhloo, M. (2020). Industry 4.0, digitization, and opportunities for sustainability. Journal of Cleaner Production, 252, 119869. [CrossRef]
  • 59. Glavič, P., Lukman, R. (2007). Review of sustainability terms and their definitions. Journal of Cleaner Production, 15(18), 1875-1885. [CrossRef]
  • 60. Sorumlu Üretim ve Tüketim | Kuresel Amaçlar. Erişim adresi https://www.kureselamaclar.org /amaclar/sorumlu-uretim-ve-tuketim/. Erişim Tarihi: 08.10.2022.
  • 61. Industry 5.0. (2022, January 10). Erişim adresi https://research-and-innovation.ec.europa.eu/research-area/industry/industry-50_en. Erişim Tarihi: 08.10.2022.
  • 62. Aleksić, I. (2021). Green pharmaceutical manufacturing: Approaches and perspectives. Archives of Pharmacy, 71(Suppl. 5), s14.
  • 63. Becker, K., Salar-Behzadi, S., Zimmer, A. (2015). Solvent-free melting techniques for the preparation of lipid-based solid oral formulations. Pharmaceutical Research, 32(5), 1519-1545. [CrossRef]
  • 64. Bose, S., Bogner, R.H. (2007). Solventless pharmaceutical coating processes: A review. Pharmaceutical Development and Technology, 12(2), 115-131. [CrossRef]
  • 65. Belkhir, L., Elmeligi, A. (2019). Carbon footprint of the global pharmaceutical industry and relative impact of its major players. Journal of Cleaner Production, 214, 185-194. [CrossRef]
  • 66. Ford, S., Despeisse, M. (2016). Additive manufacturing and sustainability: an exploratory study of the advantages and challenges. Journal of Cleaner Production, 137, 1573-1587. [CrossRef]
  • 67. Jin, M., Tang, R., Ji, Y., Liu, F., Gao, L., Huisingh, D. (2017). Impact of advanced manufacturing on sustainability: An overview of the special volume on advanced manufacturing for sustainability and low fossil carbon emissions. Journal of Cleaner Production, 161, 69-74. [CrossRef]
  • 68. Beier, G., Niehoff, S., Ziems, T., Xue, B. (2017). Sustainability aspects of a digitalized industry-A comparative study from China and Germany. International Journal of Precision Engineering and Manufacturing-Green Technology, 4(2), 227-234. [CrossRef]
  • 69. Winkle, H.N., Nasr, M.M. (2011, September 2). FDA Perspectives: Understanding Challenges to Quality by Design. Erişim adresi https://www.pharmtech.com/view/fda-perspectives-understanding challenges-quality-design. Erişim Tarihi: 20.11.2022.
  • 70. Lou, H., Lian, B., Hageman, M.J. (2021). Applications of machine learning in solid oral dosage form development. Journal of Pharmaceutical Sciences, 110(9), 3150-3165. [CrossRef]
  • 71. Caudai, C., Galizia, A., Geraci, F., Le Pera, L., Morea, V., Salerno, E., Via, A., Colombo, T. (2021). AI applications in functional genomics. Computational and Structural Biotechnology Journal, 19, 5762-5790. [CrossRef]
  • 72. Schmidt, A., Frey, J., Hillen, D., Horbelt, J., Schandar, M., Schneider, D., Sorokos, I. (2021). A framework for automated quality assurance and documentation for pharma 4.0. In International Conference on Computer Safety, Reliability and Security (pp. 226-239). Springer, Cham. [CrossRef]
  • 73. Manogaran, G., Thota, C., Lopez, D., Sundarasekar, R. (2017). Big data security intelligence for healthcare industry 4.0. In Cybersecurity for Industry 4.0 (pp. 103-126). Springer, Cham. [CrossRef]
  • 74. Vrchota, J., Pech, M., Rolínek, L., Bednář, J. (2020). Sustainability outcomes of green processes in relation to industry 4.0 in manufacturing: Systematic review. Sustainability, 12(15), 5968. [CrossRef]
There are 74 citations in total.

Details

Primary Language Turkish
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Collection
Authors

Gözde Bebek 0000-0001-9593-8373

Yagmur Akdag 0000-0003-4139-9815

Levent Öner 0000-0002-6510-7680

Early Pub Date July 17, 2023
Publication Date September 20, 2023
Submission Date December 29, 2022
Acceptance Date April 29, 2023
Published in Issue Year 2023

Cite

APA Bebek, G., Akdag, Y., & Öner, L. (2023). FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI. Journal of Faculty of Pharmacy of Ankara University, 47(3), 1058-1070. https://doi.org/10.33483/jfpau.1225743
AMA Bebek G, Akdag Y, Öner L. FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI. Ankara Ecz. Fak. Derg. September 2023;47(3):1058-1070. doi:10.33483/jfpau.1225743
Chicago Bebek, Gözde, Yagmur Akdag, and Levent Öner. “FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI”. Journal of Faculty of Pharmacy of Ankara University 47, no. 3 (September 2023): 1058-70. https://doi.org/10.33483/jfpau.1225743.
EndNote Bebek G, Akdag Y, Öner L (September 1, 2023) FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI. Journal of Faculty of Pharmacy of Ankara University 47 3 1058–1070.
IEEE G. Bebek, Y. Akdag, and L. Öner, “FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI”, Ankara Ecz. Fak. Derg., vol. 47, no. 3, pp. 1058–1070, 2023, doi: 10.33483/jfpau.1225743.
ISNAD Bebek, Gözde et al. “FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI”. Journal of Faculty of Pharmacy of Ankara University 47/3 (September 2023), 1058-1070. https://doi.org/10.33483/jfpau.1225743.
JAMA Bebek G, Akdag Y, Öner L. FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI. Ankara Ecz. Fak. Derg. 2023;47:1058–1070.
MLA Bebek, Gözde et al. “FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI”. Journal of Faculty of Pharmacy of Ankara University, vol. 47, no. 3, 2023, pp. 1058-70, doi:10.33483/jfpau.1225743.
Vancouver Bebek G, Akdag Y, Öner L. FARMASÖTİK ENDÜSTRİDE FARMA 4.0 YAKLAŞIMI. Ankara Ecz. Fak. Derg. 2023;47(3):1058-70.

Kapsam ve Amaç

Ankara Üniversitesi Eczacılık Fakültesi Dergisi, açık erişim, hakemli bir dergi olup Türkçe veya İngilizce olarak farmasötik bilimler alanındaki önemli gelişmeleri içeren orijinal araştırmalar, derlemeler ve kısa bildiriler için uluslararası bir yayım ortamıdır. Bilimsel toplantılarda sunulan bildiriler supleman özel sayısı olarak dergide yayımlanabilir. Ayrıca, tüm farmasötik alandaki gelecek ve önceki ulusal ve uluslararası bilimsel toplantılar ile sosyal aktiviteleri içerir.