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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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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. |
format | Online Article Text |
id | pubmed-5784736 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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