Simultaneous confidence interval methods for analytical similarity assessment
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2019.1657142
Abstract: ABSTRACT In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar. When there were multiple references, similarity among the reference products is… read more here.
Keywords: simultaneous confidence; similarity assessment; similarity; analytical similarity ... See more keywords
Analytical Similarity Assessment of MYL-1402O to Reference Bevacizumab.
Sign Up to like & getrecommendations! Published in 2021 at "Expert opinion on biological therapy"
DOI: 10.1080/14712598.2021.1973426
Abstract: BACKGROUND Bevacizumab (BEV) is a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to vascular endothelial growth factor (VEGF)-A and acts as an antiangiogenic agent. It is approved for treatment of many cancer indications, including… read more here.
Keywords: bev; 1402o reference; analytical similarity; myl 1402o ... See more keywords
Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study
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DOI: 10.1080/19420862.2017.1402996
Abstract: ABSTRACT Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in… read more here.
Keywords: analytical similarity; similarity; innovator product; similarity biosimilar ... See more keywords