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10.4161/mabs.29848 http://scihub22266oqcxt.onion/10.4161/mabs.29848 C4622966!4622966!25517301     free     free     free Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       MAbs 2014 ; 6 (5): 1155-62 Nephropedia Template TP {{tp|p=25517301|t=2014. Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union |pdf=|usr=}}{{25517301}} gab.com Text Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union JO: MAbs http://www.kidney.de/pget.php?&tw=1&pmid=25517301 #FOAvip The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies. Twit Text FOAVip Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union ????MAbs http://www.kidney.de/pget.php?&tw=1&pmid=25517301 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25517301 #FOAvip English Wikipedia <ref>{{Cite pmid|25517301}}</ref> Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union #MMPMID25517301 van Aerts LA; De Smet K; Reichmann G; van der Laan JW; Schneider CK MAbs 2014[Sep]; 6 (5): 1155-62 PMID25517301show ga The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies. äBiosimilars entering the clinic without animal studies: A paradigm shi(epmc).pdf DeepDyve Pubget Overpricing