A brief concept of comparability study for manufacturing process change of biological products and its difference from biosimilar products
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Aug 15, 2018
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วิริยะบัญชา ว, สานุพันธ์ อ. A brief concept of comparability study for manufacturing process change of biological products and its difference from biosimilar products. Thai Food and Drug J [Internet]. 2018 Aug. 15 [cited 2024 Nov. 23];25(2):4-10. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/140315
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References
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2.สำนักงานคณะกรรมการอาหารและยา. (2556, 22 ตุลาคม). ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง เอกสารหลักฐานการขอขึ้นทะเบียนตำรับยาชีววัตถุคล้ายคลึง.
3.Schelegel M, Bobinnec Y. Comparability protocols for biotechnological products: A five step methodology. Bioprocess international. 2013; 11(6): 30-41.
4.International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Q5E: Comparability of biotechnological/biological products subject to changes in their manufacturing process. 2004. [Available in: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/.../Q5E_Guideline.pdf.]
5.Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004; 22(11): 1383-1391.
6.US Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2015. [Available in: https://www.fda.gov/downloads/drug/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf]
7.Chow SC, Song F, Bai H. Analytical similarity assessment in biosimilar studies. The AAPS Journal. 2016; 18: 670-7.
8.Azevedo V, Hassett B, Fonseca JE, Atsumi T, Coindreau J, Jacobs I, Mahgoub E, O'Brien J, Singh E, Vicik S, Fitzpatrick B. Differentiating biosimilarity and comparability in biotherapeutics. Clin Rheumatol. 2016; 35: 2877-86.
2.สำนักงานคณะกรรมการอาหารและยา. (2556, 22 ตุลาคม). ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง เอกสารหลักฐานการขอขึ้นทะเบียนตำรับยาชีววัตถุคล้ายคลึง.
3.Schelegel M, Bobinnec Y. Comparability protocols for biotechnological products: A five step methodology. Bioprocess international. 2013; 11(6): 30-41.
4.International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Q5E: Comparability of biotechnological/biological products subject to changes in their manufacturing process. 2004. [Available in: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/.../Q5E_Guideline.pdf.]
5.Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004; 22(11): 1383-1391.
6.US Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2015. [Available in: https://www.fda.gov/downloads/drug/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf]
7.Chow SC, Song F, Bai H. Analytical similarity assessment in biosimilar studies. The AAPS Journal. 2016; 18: 670-7.
8.Azevedo V, Hassett B, Fonseca JE, Atsumi T, Coindreau J, Jacobs I, Mahgoub E, O'Brien J, Singh E, Vicik S, Fitzpatrick B. Differentiating biosimilarity and comparability in biotherapeutics. Clin Rheumatol. 2016; 35: 2877-86.