Multiple-time-point dissolution specifications for a sampling acceptance plan.
J Biopharm Stat
; 7(2): 259-70, 1997 May.
Article
em En
| MEDLINE
| ID: mdl-9136068
ABSTRACT
In dissolution testing, multiple dissolution measurements at specific time points are used to obtain the dissolution characteristics for most extended-release and some immediate-release drug products. This paper presents a general procedure for defining specifications by a multivariate confidence region or by simultaneous confidence limits on the dissolution values of individual time points. The confidence regions and simultaneous confidence limits were estimated using two approaches the first approach assumed a multivariate normal distribution on the multiple dissolution values and the second approach used the bootstrap resampling method. The multivariate confidence region was constructed using the Hotelling's T2 statistic (equivalently, Mahalanobis distance D2), and the simultaneous confidence limits were based on the Mahalanobis statistic as well as on the Bonterroni adjustment. The Mahalanobis simultaneous confidence limits specification criteria have the overall false out-of-specification rate too low in both parametric and bootstrap approaches.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
Problema de saúde:
1_financiamento_saude
Assunto principal:
Solubilidade
/
Química Farmacêutica
Tipo de estudo:
Health_economic_evaluation
/
Prognostic_studies
Idioma:
En
Revista:
J Biopharm Stat
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
1997
Tipo de documento:
Article
País de afiliação:
Estados Unidos