Using accelerated drug stability results to inform long-term studies in shelf life determination.
Stat Med
; 37(17): 2599-2615, 2018 07 30.
Article
en En
| MEDLINE
| ID: mdl-29766536
ABSTRACT
In the pharmaceutical industry, the shelf life of a drug product is determined by data gathered from stability studies and is intended to provide consumers with a high degree of confidence that the drug retains its strength, quality, and purity under appropriate storage conditions. In this paper, we focus on liquid drug formulations and propose a Bayesian approach to estimate a drug product's shelf life, where prior knowledge gained from the accelerated study conducted during the drug development stage is used to inform the long-term study. Classical and nonlinear Arrhenius regression models are considered for the accelerated conditions, and two examples are given where posterior results from the accelerated study are used to construct priors for a long-term stability study.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Análisis de Regresión
/
Teorema de Bayes
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Dinámicas no Lineales
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Estabilidad de Medicamentos
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Stat Med
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos