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10.1208/s12248-013-9464-8 http://scihub22266oqcxt.onion/10.1208/s12248-013-9464-8 23408094ModelingSimulationandTranslationFrameworkforthePreclinicalDevelopmentofMonoclonalAntibodies.!3675753!23408094     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       AAPS+J 2013 ; 15 (2): 551-8 Nephropedia Template TP {{tp|p=23408094|t=2013. Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodies |pdf=|usr=}}{{23408094}} gab.com Text Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodies JO: AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=23408094 #FOAvip The industry-wide biopharmaceutical (i.e., biologic, biotherapeutic) pipeline has been growing at an astonishing rate over the last decade with the proportion of approved new biological entities to new chemical entities on the rise. As biopharmaceuticals appear to be growing in complexity in terms of their structure and mechanism of action, so are interpretation, analysis, and prediction of their quantitative pharmacology. We present here a modeling and simulation (M&S) framework for the successful preclinical development of monoclonal antibodies (as an illustrative example of biopharmaceuticals) and discuss M&S strategies for its implementation. Critical activities during early discovery, lead optimization, and the selection of starting doses for the first-in-human study are discussed in the context of pharmacokinetic-pharmacodynamic (PKPD) and M&S. It was shown that these stages of preclinical development are and should be reliant on M&S activities including systems biology (SB), systems pharmacology (SP), and translational pharmacology (TP). SB, SP, and TP provide an integrated and rationalized framework for decision making during the preclinical development phase. In addition, they provide increased target and systems understanding, describe and interpret data generated in vitro and in vivo, predict human PKPD, and provide a rationalized approach to designing the first-in-human study. Twit Text FOAVip Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodies ????AAPS J http://www.kidney.de/pget.php?&tw=1&pmid=23408094 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=23408094 #FOAvip English Wikipedia <ref>{{Cite pmid|23408094}}</ref> Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodies #MMPMID23408094 Luu KT; Kraynov E; Kuang B; Vicini P; Zhong WZ AAPS J 2013[Apr]; 15 (2): 551-8 PMID23408094show ga The industry-wide biopharmaceutical (i.e., biologic, biotherapeutic) pipeline has been growing at an astonishing rate over the last decade with the proportion of approved new biological entities to new chemical entities on the rise. As biopharmaceuticals appear to be growing in complexity in terms of their structure and mechanism of action, so are interpretation, analysis, and prediction of their quantitative pharmacology. We present here a modeling and simulation (M&S) framework for the successful preclinical development of monoclonal antibodies (as an illustrative example of biopharmaceuticals) and discuss M&S strategies for its implementation. Critical activities during early discovery, lead optimization, and the selection of starting doses for the first-in-human study are discussed in the context of pharmacokinetic-pharmacodynamic (PKPD) and M&S. It was shown that these stages of preclinical development are and should be reliant on M&S activities including systems biology (SB), systems pharmacology (SP), and translational pharmacology (TP). SB, SP, and TP provide an integrated and rationalized framework for decision making during the preclinical development phase. In addition, they provide increased target and systems understanding, describe and interpret data generated in vitro and in vivo, predict human PKPD, and provide a rationalized approach to designing the first-in-human study. |*Computer Simulation[MESH] |*Models, Biological[MESH] |Animals[MESH] |Antibodies, Monoclonal/administration & dosage/pharmacokinetics/*pharmacology[MESH] |Decision Support Techniques[MESH] |Disease Models, Animal[MESH] |Drug Dosage Calculations[MESH] |Drug Evaluation, Preclinical/*methods[MESH] |Humans[MESH] |Nonlinear Dynamics[MESH] |Systems Biology[MESH]Modeling, simulation, and translation framework for the preclinical de(epmc).pdf DeepDyve Pubget Overpricing