Biyobenzer ilaçların preklinik ve klinik performanslarının değerlendirilmesi
Öz
Anahtar Kelimeler
Kaynakça
- EMEA/CHMP/BMWP/42832/2005 Rev.1. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 18 December 2014.
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. Guidance for Industry. https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. May 2019, Biosimilars.
- https://www.genengnews.com/a-lists/top-15-best-selling-drugs-of-2018/
- https://www.statista.com/statistics/299138/top-selling-biotech-drugs-based-on-revenue/
- EMEA/CHMP/BMWP/118264/2007 Rev.1. Committee for Medicinal products for Human (CHMP) Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins. 10 November 2016.
- EMEA/CHMP/BMWP/32775/2005_Rev.1. Committee for Medicinal products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. 26 February 2015.
- EMEA/CHMP/BMWP/301636/2008 Rev.1. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. 28 June 2018.
- EMEA/CHMP/BMWP/31329/2005. Guidance on Similar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor. London, 22 February 2006.
Ayrıntılar
Birincil Dil
Türkçe
Konular
Sağlık Kurumları Yönetimi
Bölüm
Olgu Sunumu
Yazarlar
Turgut Emrah Bozkurt
0000-0001-8650-176X
Türkiye
Yayımlanma Tarihi
20 Ocak 2021
Gönderilme Tarihi
6 Nisan 2020
Kabul Tarihi
28 Ağustos 2020
Yayımlandığı Sayı
Yıl 2021