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10.1097/MJT.0000000000000391 http://scihub22266oqcxt.onion/10.1097/MJT.0000000000000391 C5102275!5102275!26766293     free     free     free       Am+J+Ther 2016 ; 23 (6): e1903-10 Nephropedia Template TP {{tp|p=26766293|t=2016. Statistical Primer on Biosimilar Clinical Development |pdf=|usr=}}{{26766293}} gab.com Text Statistical Primer on Biosimilar Clinical Development JO: Am J Ther http://www.kidney.de/pget.php?&tw=1&pmid=26766293 #FOAvip A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available. Twit Text FOAVip Statistical Primer on Biosimilar Clinical Development ????Am J Ther http://www.kidney.de/pget.php?&tw=1&pmid=26766293 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26766293 #FOAvip English Wikipedia <ref>{{Cite pmid|26766293}}</ref> Statistical Primer on Biosimilar Clinical Development #MMPMID26766293 Isakov L; Jin B; Jacobs IA Am J Ther 2016[Nov]; 23 (6): e1903-10 PMID26766293show ga A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available. äStatistical Primer on Biosimilar Clinical Development (epmc).pdf DeepDyve Pubget Overpricing