KaydedilenlerDerginizi ekleyin

Dergiler / Marmara Pharmaceutical Journal / 2018 / Cilt: 22 - Sayı: 4

The role of the pharmacist from development to pharmacovigilance of biosimilars

İmge KUNTER
Halimat Olusola BALOGUN
Gönül Zişan ŞAHİN
Sayfa
469–473
DOI
—
🏛️Bu makalenin bibliyografik verileri ve tam metin bağlantısı DergiPark üzerinden sağlanmıştır.
DergiPark Kaydı ↗
✨

Yapay Zeka Hızlı Bakış & Çıkarımlar

AI Insight
⚡ TL;DR(1 Cümlede Hızlı Çıkarım)

We also emphasized the role of pharmacist at development, manufacturing, dispensing, post-marketing pharmacovigilance, regulations and usage of biosimilars.

📌 3 Maddede Bu Makale

🎯
Amaç & Hipotez:Biologics such as vaccines, recombinant proteins and antibodies are used to treat or prevent different chronic and complex diseases and they have a high market share.
📊
Temel Bulgular & Veri:Improvements in biotechnology, leads increased production and use of these products.
💡
Sonuç & Katkı:We also emphasized the role of pharmacist at development, manufacturing, dispensing, post-marketing pharmacovigilance, regulations and usage of biosimilars.
🔬Tür:Araştırma Makalesi
📍Kapsam:Genişletilmiş Akademik Örneklem
⚙️Değişkenler:Alan Parametreleri

Özet

Biologics such as vaccines, recombinant proteins and antibodies are used to treat or prevent different chronic and complex diseases and they have a high market share. Improvements in biotechnology, leads increased production and use of these products. Because of high manufacturing cost, they are expensive and have significant drawbacks about their use and patient accessibility. Biosimilars are cost-effective therapeutic alternatives of biologics, which can be marketed after the expiry of the patent of the reference biologic. Biosimilars can provide cheaper alternatives and they can help reduce health care expenditure significantly. Although there are many publications related to the importance of biosimilars in the literature, there are not enough studies on the role of the pharmacist from development to pharmacovigilance of these drugs. In this article, besides the importance of these drugs we addressed the crucial contribution of the pharmacists in preparation of biosimilar drugs, establishing regulations and approval pathways to take place in the market and the investigation of the side effects after marketing. We also emphasized the role of pharmacist at development, manufacturing, dispensing, post-marketing pharmacovigilance, regulations and usage of biosimilars.

🔖

Bu Makaleye Atıf Yap

KUNTER, İ., BALOGUN, H. O., ŞAHİN, G. Z. (2018). The role of the pharmacist from development to pharmacovigilance of biosimilars. Marmara Pharmaceutical Journal, Cilt: 22 - Sayı: 4, 469–473. https://ajindex.com/articles/283592

📄 Tam Metin PDF Okuyucu

📄

PDF görüntüleyici hazırlanıyor...

Kaynakça (15)

  1. Dolinar R, Reilly M. The future of biological therapy: a pathway forward for biosimilars. GaBI J. 2013; 2(1): 36–40
  2. Crommelin DJA, Storm G, Verrijk R, Leedeb L, Jiskoot W, Hennink WE. Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003; 266(1-2): 3–16
  3. Rader RA. (Re)defining biopharmaceutical. Nat Biotechnol. 2008; 26(7): 743–751
  4. Sekhon BS. Biopharmaceuticals: an overview Bhupinder. Thai J Pharm Sci. 2010; 34: 1–19
  5. Heinemann L, Khatami H, McKinnon R, Home P. An overview of current regulatory requirements for approval of biosimilar insulins. Diabetes Technol Ther. 2015; 17(7): 1–17
  6. Dempke WCM, Fenchel K, Uciechowski P, Dale SP. Second- and third-generation drugs for immuno-oncology treatment—The more the better? Eur J Cancer. 2017; 74: 55–72
  7. Morrow T, Felcone LH. Defining the difference: What makes biologics unique. Biotechnol Healthc. 2004; 1(4): 24–9
  8. Emmanouilides CE, Karampola MI, Beredima M. Biosimilars: Hope and concern. J Oncol Pharm Pract. 2015; 22(4): 618–624
  9. U.S Food and Drug Administration Global Engagement - U.S. Food and Drug Administration. Off Int ProgramsFDA 2011; 1–44. https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM298578.pdf (accessed May 22, 2017)
  10. Aitken M. The Global Use of Medicines: Outlook Through 2015. 2011; 1-42
  11. Aitken M, Kleinrock M, Lyle J, Nass D, Caskey L. Global Outlook for Medicines Through 2018. IMS Inst. Healthc. Informatics 2014. http://static.correofarmaceutico.com/docs/2014/12/01/informe_ims.pdf (accessed december 22, 2017)
  12. Jozala AF, Geraldes DC, Tundisi LL, Feitosa VA, Breyer CA, Cardoso SL, Mazzola PG, Oliveira NL, Rangel YCO, Magalhães PO, Oliveira MA, Pessoa A Jr. Biopharmaceuticals from microorganisms: from production to purification. Braz J Microbiol. 2016; 47: 51–63
  13. Davit B, Braddy AC, Conner DP, Yu LX. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J. 2013; 15(4): 974–990
  14. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013; 14: 1–19
  15. Gothe H, Schall I, Saverno K, Mitrovic M, Luzak A, Brixner D, Siebert U. The impact of generic substitution on heal