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10.1208/s12248-013-9534-y http://scihub22266oqcxt.onion/10.1208/s12248-013-9534-y 24114449IsExtrapolationoftheSafetyandEfficacyDatainOneIndicationtoAnotherAppropriateforBiosimilars?!3889539!24114449     free     free     free Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       AAPS+J 2014 ; 16 (1): 22-6 Nephropedia Template TP {{tp|p=24114449|t=2014. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?|pdf=|usr=}}{{24114449}} gab.com Text Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars JO: AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=24114449 #FOAvip CT-P13, the world's first biosimilar monoclonal antibody to infliximab, was approved for marketing in South Korea for all the six indications of infliximab, which Europe may follow, although the product was tested only in rheumatoid arthritis (RA) with a limited pharmacokinetic comparison in ankylosing spondylitis. However, the extrapolation of the efficacy and safety findings of CT-P13 in RA to the other indications appears scientifically challenging when assessed by the current regulatory requirements. RA is not a sensitive clinical model to detect potential differences between CT-P13 and infliximab, and other mechanisms of action than antagonizing tumor necrosis factor alpha appear to be also important, which could be different by the approved indications. Furthermore, the immunogenicity and safety profiles of CT-P13 were not sufficiently characterized in that immunogenicity potential was lowest in RA, which was even further suppressed by the concomitant use of methotrexate. Extrapolation of the safety and efficacy data in one indication to another may be inappropriate for biosimilars unless backed up by strong scientific justification, which may include the mechanistic exposure-relationship approach. Therefore, regulatory agencies need to exercise caution before granting extrapolated indications to biosimilars. Twit Text FOAVip Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars ????AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=24114449 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=24114449 #FOAvip English Wikipedia <ref>{{Cite pmid|24114449}}</ref> Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? #MMPMID24114449 Lee H AAPS J 2014[Jan]; 16 (1): 22-6 PMID24114449show ga CT-P13, the world's first biosimilar monoclonal antibody to infliximab, was approved for marketing in South Korea for all the six indications of infliximab, which Europe may follow, although the product was tested only in rheumatoid arthritis (RA) with a limited pharmacokinetic comparison in ankylosing spondylitis. However, the extrapolation of the efficacy and safety findings of CT-P13 in RA to the other indications appears scientifically challenging when assessed by the current regulatory requirements. RA is not a sensitive clinical model to detect potential differences between CT-P13 and infliximab, and other mechanisms of action than antagonizing tumor necrosis factor alpha appear to be also important, which could be different by the approved indications. Furthermore, the immunogenicity and safety profiles of CT-P13 were not sufficiently characterized in that immunogenicity potential was lowest in RA, which was even further suppressed by the concomitant use of methotrexate. Extrapolation of the safety and efficacy data in one indication to another may be inappropriate for biosimilars unless backed up by strong scientific justification, which may include the mechanistic exposure-relationship approach. Therefore, regulatory agencies need to exercise caution before granting extrapolated indications to biosimilars. |*Drug and Narcotic Control[MESH] |Antibodies, Monoclonal/pharmacology/*therapeutic use[MESH] |Antirheumatic Agents/pharmacology/*therapeutic use[MESH] |Arthritis, Rheumatoid/*drug therapy[MESH] |Biosimilar Pharmaceuticals/*adverse effects[MESH] |Humans[MESH] |Immunogenetic Phenomena[MESH] |Infliximab[MESH]Is extrapolation of the safety and efficacy data in one indication to (epmc).pdf DeepDyve Pubget Overpricing