Your browser doesn't support javascript.
loading
Models for Counts and Particle Size Distributions of Subvisible Particle Data.
Quiroz, Jorge; Vazquez, Elsa M; Wilson, Jeffrey; Dabbara, Anita; Cheung, Jason K.
Afiliação
  • Quiroz J; Research CMC Statistics, Merck & Co., Inc., Kenilworth, NJ; jorge.quiroz@merck.com.
  • Vazquez EM; Arizona State University, Tempe, AZ; and.
  • Wilson J; Arizona State University, Tempe, AZ; and.
  • Dabbara A; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ.
  • Cheung JK; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ.
PDA J Pharm Sci Technol ; 75(3): 213-229, 2021.
Article em En | MEDLINE | ID: mdl-33199515
ABSTRACT
Traditional statistical analyses of subvisible particle data are usually based on either descriptive statistics, normal-based methods, or standard Poisson models. These methods often do not adequately describe the counts or particle size distribution. They usually ignore relevant information represented in the data, such as count correlation. Therefore, any meaningful analyses of subvisible particle data require a reasonable representation of counts and particle size distribution and the correlation in the data. Such comprehensive approaches are not widely available or used when analyzing subvisible particle data. In this article, we propose the use of generalized linear mixed models to analyze the counts and the particle size distribution of subvisible particle data. These models make optimal use of the information in the data and allow flexible approaches for the analyses of a wide range of data structures. They are readily accessible to practitioners through the use of modern statistical software. These models are demonstrated with two numerical examples using two different data structures.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Modelos Estatísticos Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Modelos Estatísticos Idioma: En Ano de publicação: 2021 Tipo de documento: Article