Model-Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab.
CPT Pharmacometrics Syst Pharmacol
; 7(1): 5-15, 2018 01.
Article
em En
| MEDLINE
| ID: mdl-28836356
ABSTRACT
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Produtos Biológicos
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Descoberta de Drogas
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Desenvolvimento de Medicamentos
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Modelos Biológicos
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Anticorpos Monoclonais
Tipo de estudo:
Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article