Statistical Methods for Quality Equivalence of Topical Products. 0.5 mg/g Betamethasone Ointment as a Case-Study

Autor:	Jordi Ocaña, Toni Monleón-Getino, Virginia Merino, Daniel Peris, Lluís Soler
Jazyk:	angličtina
Rok vydání:	2020
Předmět:	Fieller’s confidence interval equivalence test batch effect multiple quality variables principal component analysis Pharmacy and materia medica RS1-441
Zdroj:	Pharmaceutics, Vol 12, Iss 4, p 318 (2020)
Druh dokumentu:	article
ISSN:	1999-4923
DOI:	10.3390/pharmaceutics12040318
Popis:	This study examines the statistical implications, and their possible implementation, of the “Draft guideline on quality and equivalence of topical products” issued by the European Medicines Agency in 2018, with particular focus on the section devoted to quality equivalence of physical properties. A new confidence interval to conduct the quality equivalence test and a way to cope with the multiplicity of quality parameters are presented and discussed. As an example, the results and the statistical analysis of a study on betamethasone 0.5 mg/g ointment are presented. It is suggested that the equivalence limits proposed in the draft guideline are overly strict: It is as difficult to declare quality equivalence between two packaging formats of the same reference product as to declare quality equivalence between the reference and the test product.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/4067b8859ef84488bb5f318a3edecd10 Zobrazit plný text záznamu View record in DOAJ Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.