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Abstract

The trend of combining drugs and devices has brought about advancements in medical product development, regulatory approval, and business involvement. These combination products are designed with modern links between key technologies and complementary elements, while still maintaining their fundamental purpose. To better understand the benefits and drawbacks of these combination medications, we will look at case studies of drug-device stents and transdermal patches. It seems that this generation of combination products has created a new, high-value area, as evidenced by advancements in product control and the realization that the competitive advantage lies in the sophistication of the mix. Recent studies show that combining technology, medicine, and biologics creates a developing opportunity. According to our analysis, a new type of combination product's first product includes both the regulator and the sponsor. If this first product is granted a license, it can greatly reduce uncertainty around the entire class of combination medications, establishing a leading regulatory center. The sponsor of a new type of combination product is crucial in reducing uncertainty by helping decision-makers understand the fundamental objective of the combination product.

Keywords

Drug-device combination, combination product, Drug, Device, Biological products, FDA

Reference

  1. Latoz, C., Larkin, L., & Huynh-Ba, K. (2023). Stability considerations for drug-device combination products-21 CFR part 4 update. AAPS Open, 9(1), 1-14.
  2. Choi, S. H., Wang, Y., Conti, D. S., Raney, S. G., Delvadia, R., Leboeuf, A. A., & Witzmann, K. (2018). Generic drug-device combination products: Regulatory and scientific considerations. International Journal of Pharmaceutics, 544(2), 443-454.
  3. Cooke, E. (2022). Preparing Europe for future health threats and crises? the European Medicines Agency; ensures safe and effective medicines and medical devices. Eurosurveillance, 27(42), 2200798.
  4. Pourkavoos, N. (2012). Unique risks, benefits, and challenges of developing drug-drug combination products in a pharmaceutical industrial setting. Combination Products in Therapy, 2, 1-31.
  5. Couto, D. S., Perez-Breva, L., Saraiva, P., & Cooney, C. L. (2012). Lessons from innovation in drug-device combination products. Advanced drug delivery reviews, 64(1), 69-77.
  6. Chandrasekaran, G., & Rajalakshmi, A. N. (2019). Fixed dose combination products as Oro-dispersible tablets: A review. Journal of Drug Delivery and Therapeutics, 9(2), 563-573.
  7. Netland, P. A., & Tanna, A. P. (Eds.). (2020). Glaucoma medical therapy: principles and management. Kugler Publications.
  8. Mitra, A., & Wu, Y. (2012). Challenges and opportunities in achieving bioequivalence for fixed-dose combination products. The AAPS journal, 14, 646-655.
  9. Mitra, A., & Wu, Y. (2012). Challenges and opportunities in achieving bioequivalence for fixed-dose combination products. The AAPS journal, 14, 646-655.
  10. Tian, J., Song, X., Wang, Y., Cheng, M., Lu, S., Xu, W., ... & Zhang, X. (2022). Regulatory perspectives of combination products. Bioactive Materials, 10, 492-503.
  11. Lehár, J., Krueger, A. S., Avery, W., Heilbut, A. M., Johansen, L. M., Price, E. R., ... & Borisy, A. A. (2009). Synergistic drug combinations tend to improve therapeutically relevant selectivity. Nature Biotechnology, 27(7), 659-666.
  12. Tian, J., Song, X., Wang, Y., Cheng, M., Lu, S., Xu, W., ... & Zhang, X. (2022). Regulatory perspectives of combination products. Bioactive Materials, 10, 492-503.
  13. Tian, J., Song, X., Wang, Y., Cheng, M., Lu, S., Xu, W., ... & Zhang, X. (2022). Regulatory perspectives of combination products. Bioactive Materials, 10, 492-503.
  14. Verma, R. K., & Garg, S. (2001). Drug delivery technologies and future directions. Pharm. Technol, 25(2), 1-14.
  15. Tiwari, G., Tiwari, R., Sriwastawa, B., Bhati, L., Pandey, S., Pandey, P., & Bannerjee, S. K. (2012). Drug delivery systems: An updated review. International journal of pharmaceutical investigation, 2(1), 2.
  16. Vargason, A. M., Anselmo, A. C., & Mitragotri, S. (2021). The evolution of commercial drug delivery technologies. Nature Biomedical Engineering, 5(9), 951-967.
  17. Vargason, A. M., Anselmo, A. C., & Mitragotri, S. (2021). The evolution of commercial drug delivery technologies. Nature Biomedical Engineering, 5(9), 951-967.
  18. Uemura, N., Kasanuki, H., & Umezu, M. (2021). New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions. Therapeutic Innovation & Regulatory Science, 55, 807-817.
  19. Kumoluyi, R., & Khanolkar, A. (2022). Risk Management in Drug-Device Combination Product Development. Therapeutic Innovation & Regulatory Science, 56(5), 685-688.
  20. Panchal, K., Katke, S., Dash, S. K., Gaur, A., Shinde, A., Saha, N., ... & Chaurasiya, A. (2023). An expanding horizon of complex injectable products: Development and regulatory considerations. Drug Delivery and Translational Research, 13(2), 433-472
  21. https://www.propharmagroup.com/thought-leadership/the-unique-challenges-of-gaining-approval-for-drug-device-combos
  22. https://corpbiz.io/learning/challenges-faced-in-drug-device-combination-products/#Challenges_Faced_In_Drug_Device_Combination_Products
  23. https://a3p.org/wp-content/uploads/2020/04/produits-combines-injectables-2-vague-65-a3p.png
  24. https://corpbiz.io/learning/challenges-faced-in-drug-device-combination-products/#Challenges_Faced_In_Drug_Device_Combination_Products

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Yashashri K. Deore
Corresponding author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Sakshi V. Dashpute
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Vaibhav B. Gunjal
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Sejal R. Pagar
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Shivraj P. Jadhav
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Dhananjay M. Patil
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

Yashashri K. Deore*, Sakshi V. Dashpute, Vaibhav B. Gunjal, Sejal R. Pagar, Shivraj P. Jadhav, Dhananjay M. Patil, A Comprehensive Review Of Drug-Device Combination, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 56-70. https://doi.org/10.5281/zenodo.10065508

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