A case study of modeling and exposure-response prediction for count data.
J Biopharm Stat
; 24(5): 1073-90, 2014.
Article
en En
| MEDLINE
| ID: mdl-24914574
ABSTRACT
Even with two doses of an experimental drug in Phase III studies, with the commonly used approach for assessing treatment effects of individual doses, it may still be difficult to determine the final commercial dose. In such a scenario, with plasma concentration data collected in the studies, a modeling approach can be applied to predict treatment effects at different plasma concentration levels. Through an established relationship between plasma concentration and dose, the treatment effects of doses not studied in the Phase III studies can then be predicted. The results can further be applied to justify the final dose confirmation or selection. In this article, a Phase III program example with count data as the primary endpoint in the multiple sclerosis area is used to illustrate the application of such a technique for dose confirmation. Several models, such as the overdispersion Poisson model, negative binomial model, and recurrent event models, are considered. The negative binomial model is preferable due to better data fitting and the capability of within-treatment assessment and between-treatment comparison.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Preparaciones Farmacéuticas
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Modelos Estadísticos
/
Ensayos Clínicos Fase III como Asunto
/
Modelos Biológicos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
J Biopharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos