Testing assay linearity over a pre-specified range.
J Biopharm Stat
; 25(2): 339-50, 2015.
Article
em En
| MEDLINE
| ID: mdl-25356663
ABSTRACT
Validation of linearity is a regulatory requirement. Although many methods are proposed, they suffer from several deficiencies including difficulties of setting fit-for-purpose acceptable limits, dependency on concentration levels used in linearity experiment, and challenges in implementation for statistically lay users. In this article, a statistical procedure for testing linearity is proposed. The method uses a two one-sided test (TOST) of equivalence to evaluate the bias that can result from approximating a higher-order polynomial response with a linear function. By using orthogonal polynomials and generalized pivotal quantity analysis, the method provides a closed-form solution, thus making linearity testing easy to implement.
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Base de dados:
MEDLINE
Assunto principal:
Biofarmácia
/
Modelos Estatísticos
/
Tecnologia Farmacêutica
Tipo de estudo:
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
J Biopharm Stat
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Estados Unidos