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Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab

Drug development is a lengthy, costly process with low probability of success. Biopharmaceuticals are highly specific molecules, with efficacy and safety closely tied to target biology and pharmacology. The “learning−predicting−confirming” continuum by translational and clinical modeling and simulat...

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Autores principales: Wang, Bing, Wu, Chi‐Yuan, Jin, Denise, Vicini, Paolo, Roskos, Lorin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5784736/
https://www.ncbi.nlm.nih.gov/pubmed/28836356
http://dx.doi.org/10.1002/psp4.12245
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author Wang, Bing
Wu, Chi‐Yuan
Jin, Denise
Vicini, Paolo
Roskos, Lorin
author_facet Wang, Bing
Wu, Chi‐Yuan
Jin, Denise
Vicini, Paolo
Roskos, Lorin
author_sort Wang, Bing
collection PubMed
description Drug development is a lengthy, costly process with low probability of success. Biopharmaceuticals are highly specific molecules, with efficacy and safety closely tied to target biology and pharmacology. The “learning−predicting−confirming” continuum by translational and clinical modeling and simulation (M&S) was implemented at every decision point for mavrilimumab, a human monoclonal antibody in development for rheumatoid arthritis (RA). This tutorial uses mavrilimumab as an example to demonstrate rational discovery, preclinical development, clinical study design, and dose selection of biotherapeutics by M&S.
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spelling pubmed-57847362018-02-07 Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab Wang, Bing Wu, Chi‐Yuan Jin, Denise Vicini, Paolo Roskos, Lorin CPT Pharmacometrics Syst Pharmacol Tutorial Drug development is a lengthy, costly process with low probability of success. Biopharmaceuticals are highly specific molecules, with efficacy and safety closely tied to target biology and pharmacology. The “learning−predicting−confirming” continuum by translational and clinical modeling and simulation (M&S) was implemented at every decision point for mavrilimumab, a human monoclonal antibody in development for rheumatoid arthritis (RA). This tutorial uses mavrilimumab as an example to demonstrate rational discovery, preclinical development, clinical study design, and dose selection of biotherapeutics by M&S. John Wiley and Sons Inc. 2017-11-23 2018-01 /pmc/articles/PMC5784736/ /pubmed/28836356 http://dx.doi.org/10.1002/psp4.12245 Text en © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Tutorial
Wang, Bing
Wu, Chi‐Yuan
Jin, Denise
Vicini, Paolo
Roskos, Lorin
Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title_full Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title_fullStr Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title_full_unstemmed Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title_short Model‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
title_sort model‐based discovery and development of biopharmaceuticals: a case study of mavrilimumab
topic Tutorial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5784736/
https://www.ncbi.nlm.nih.gov/pubmed/28836356
http://dx.doi.org/10.1002/psp4.12245
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