Statistical Assessment of Mean Differences between Two Dissolution Data Sets

Tsong, Yi; Hammerstrom, Thomas; Sathe, Pradeep; Shah, Vinod P.

doi:10.1177/009286159603000427

Cited by 84 publications

(68 citation statements)

References 1 publication

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“…6) A relatively small number of tablets (six tablets) and the limited time points (up to nine) used for the analysis in this study would explain the different conclusions on dissolution similarity through the MV method compared to MHLW f 2 .…”

Section: Resultsmentioning

confidence: 83%

“…The MV method was applied as previously described 6) using Microsoft Excel. Global similarity limits were set based on the average dissolutions of reference products to ±15, ±12, and ±9% (the average dissolution of reference product reaches 85%, between 50 and 85%, and below 50% at the specified testing time, respectively) according to MHLW guidelines.…”

Section: Methodsmentioning

confidence: 99%

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Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: f2 Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Yoshida¹,

Shibata²,

Izutsu³

et al. 2017

Biological & Pharmaceutical Bulletin

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2 statistics defined in the MHLW guidelines (MHLW f 2 method) and two different Method B procedures, including a bootstrap method applied with f 2 statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f 2 and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f 2 values derived from the large variation in individual dissolution rates, the MV method provided results different from those obtained through MHLW f 2 and BS methods. Analysis of actual dissolution data for products with large individual variations would provide valuable information towards an enhanced understanding of these methods and their possible incorporation in the MHLW guidelines.

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Section: Resultsmentioning

confidence: 83%

Section: Methodsmentioning

confidence: 99%

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: f2 Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Yoshida¹,

Shibata²,

Izutsu³

et al. 2017

Biological & Pharmaceutical Bulletin

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show abstract

“…The methods proposed by Tsong et al (1996) and Saranadasa (2001) are based on a confidence set method using a multivariate normal distribution. In this article, we consider Saranadasa's (2001) proposal and give an exact solution for establishing similarity of dissolution profiles.…”

Section: Saranadasa and Krishnamoorthymentioning

confidence: 99%

A Multivariate Test for Similarity of Two Dissolution Profiles

Saranadasa

Krishnamoorthy

2005

Journal of Biopharmaceutical Statistics

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A multivariate test of size for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed by using the approach for the common mean problem in a multivariate setup due to Halperin (1961). The performance of the proposed method is compared with Intersection Union Test as well as f 2 criterion recommended by the FDA through a simulation study. All the methods are illustrated with real examples.

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“…Os métodos estatísticos utilizados (Tsong et al, 1996;Bartoszynski, et al, 2001) podem ser baseados em testes não-paramétricos, como o teste de Mann-Whitney (Bolton, 1984), o teste de Kolmogorov-Smirnov Z ou o teste do Qui quadrado) ou testes paramétricos (como a análise de variância, ou o teste de t-student) utilizando: * Apenas um tempo de dissolução; * Múltiplos tempo de dissolução; * Distância entre as curvas de dissolução.…”

Section: Métodos Estatísticosunclassified

“…Outro método independente de modelos, foi sugerido por Tsong et al (1996), com base no uso da distância de Mahalanobis (distância-M) entre dois vetores de variáveis ocasionais distribuídos normalmente:…”

Section: Equação 23unclassified

Avaliação in vitro da lioequivalência de formulações farmacêuticas

Costa¹

2002

Rev. Bras. Cienc. Farm.

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A avaliação e a comparação da liberação dos fármacos a partir das formas farmacêuticas têm preocupado a indústria farmacêutica INTRODUÇÃOA avaliação e a comparação da liberação dos fármacos a partir das formas farmacêuticas têm preocupado a indústria farmacêutica e as autoridades de registro. Sempre que se produz ou desenvolve uma forma farmacêutica sólida, é necessário garantir que os fármacos sejam liberados de modo adequado. Utilizam-se, hoje em dia, diversos métodos para ajudar a decidir se diferentes formulações liberam os seus fármacos de modo semelhante. Para a realização destes estudos utilizam-se mais freqüentemente os perfis cumulativos de fármaco ao longo do tempo em oposição aos seus perfis diferenciais.Alguns métodos para comparar perfis de liberação foram recentemente propostos (CDER, 1995; Shah, Poli, 1996, Poli et al., 1997Ju, Liaw, 1997;Fassihi, Pillay, 1998;Costa, Lobo, 2001 MÉTODOS ESTATÍSTICOSOs métodos estatísticos utilizados (Tsong et al., 1996;Bartoszynski, et al., 2001) podem ser baseados em testes não-paramétricos, como o teste de Mann-Whitney (Bolton, 1984), o teste de Kolmogorov-Smirnov Z ou o teste do Qui quadrado) ou testes paramétricos (como a

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Statistical Assessment of Mean Differences between Two Dissolution Data Sets

Cited by 84 publications

References 1 publication

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

A Multivariate Test for Similarity of Two Dissolution Profiles

Avaliação in vitro da lioequivalência de formulações farmacêuticas

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