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10.1208/s12248-011-9285-6 http://scihub22266oqcxt.onion/10.1208/s12248-011-9285-6 21630127!3144367!21630127     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       AAPS+J 2011 ; 13 (3): 405-16 Nephropedia Template TP {{tp|p=21630127|t=2011. AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development |pdf=|usr=}}{{21630127}} gab.com Text AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development JO: AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=21630127 #FOAvip Therapeutic proteins (TPs) are increasingly combined with small molecules and/or with other TPs. However preclinical tools and in vitro test systems for assessing drug interaction potential of TPs such as monoclonal antibodies, cytokines and cytokine modulators are limited. Published data suggests that clinically relevant TP-drug interactions (TP-DI) are likely from overlap in mechanisms of action, alteration in target and/or drug-disease interaction. Clinical drug interaction studies are not routinely conducted for TPs because of the logistical constraints in study design to address pharmacokinetic (PK)- and pharmacodynamic (PD)-based interactions. Different pharmaceutical companies have developed their respective question- and/or risk-based approaches for TP-DI based on the TP mechanism of action as well as patient population. During the workshop both company strategies and regulatory perspectives were discussed in depth using case studies; knowledge gaps and best practices were subsequently identified and discussed. Understanding the functional role of target, target expression and their downstream consequences were identified as important for assessing the potential for a TP-DI. Therefore, a question-and/or risk-based approach based upon the mechanism of action and patient population was proposed as a reasonable TP-DI strategy. This field continues to evolve as companies generate additional preclinical and clinical data to improve their understanding of possible mechanisms for drug interactions. Regulatory agencies are in the process of updating their recommendations to sponsors regarding the conduct of in vitro and in vivo interaction studies for new drug applications (NDAs) and biologics license applications (BLAs). Twit Text FOAVip AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development ????AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=21630127 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=21630127 #FOAvip English Wikipedia <ref>{{Cite pmid|21630127}}</ref> AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development #MMPMID21630127 Girish S; Martin SW; Peterson MC; Zhang LK; Zhao H; Balthasar J; Evers R; Zhou H; Zhu M; Klunk L; Han C; Berglund EG; Huang SM; Joshi A AAPS J 2011[Sep]; 13 (3): 405-16 PMID21630127show ga Therapeutic proteins (TPs) are increasingly combined with small molecules and/or with other TPs. However preclinical tools and in vitro test systems for assessing drug interaction potential of TPs such as monoclonal antibodies, cytokines and cytokine modulators are limited. Published data suggests that clinically relevant TP-drug interactions (TP-DI) are likely from overlap in mechanisms of action, alteration in target and/or drug-disease interaction. Clinical drug interaction studies are not routinely conducted for TPs because of the logistical constraints in study design to address pharmacokinetic (PK)- and pharmacodynamic (PD)-based interactions. Different pharmaceutical companies have developed their respective question- and/or risk-based approaches for TP-DI based on the TP mechanism of action as well as patient population. During the workshop both company strategies and regulatory perspectives were discussed in depth using case studies; knowledge gaps and best practices were subsequently identified and discussed. Understanding the functional role of target, target expression and their downstream consequences were identified as important for assessing the potential for a TP-DI. Therefore, a question-and/or risk-based approach based upon the mechanism of action and patient population was proposed as a reasonable TP-DI strategy. This field continues to evolve as companies generate additional preclinical and clinical data to improve their understanding of possible mechanisms for drug interactions. Regulatory agencies are in the process of updating their recommendations to sponsors regarding the conduct of in vitro and in vivo interaction studies for new drug applications (NDAs) and biologics license applications (BLAs). |*Clinical Trials as Topic[MESH] |*Drug Industry/methods/standards[MESH] |*Drug Interactions[MESH] |*Drug-Related Side Effects and Adverse Reactions[MESH] |Drug Discovery/*methods[MESH] |Humans[MESH]AAPS workshop report: strategies to address therapeutic protein-drug i(epmc).pdf DeepDyve Pubget Overpricing