A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.
J Pharmacokinet Pharmacodyn
; 50(3): 147-172, 2023 06.
Article
em En
| MEDLINE
| ID: mdl-36870005
ABSTRACT
Exposure-response (E-R) analyses are an integral component in the development of oncology products. Characterizing the relationship between drug exposure metrics and response allows the sponsor to use modeling and simulation to address both internal and external drug development questions (e.g., optimal dose, frequency of administration, dose adjustments for special populations). This white paper is the output of an industry-government collaboration among scientists with broad experience in E-R modeling as part of regulatory submissions. The goal of this white paper is to provide guidance on what the preferred methods for E-R analysis in oncology clinical drug development are and what metrics of exposure should be considered.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desenvolvimento de Medicamentos
/
Oncologia
Tipo de estudo:
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
J Pharmacokinet Pharmacodyn
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Estados Unidos