Statistical Methods for Quality Equivalence of Topical Products. 0.5 mg/g Betamethasone Ointment as a Case-Study
| Autor: | Toni Monleón-Getino, Lluís Soler, Virginia Merino, Jordi Ocaña, Daniel Peris |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Operations research
principal component analysis Pharmaceutical Science lcsh:RS1-441 Batch effect 030226 pharmacology & pharmacy 01 natural sciences Article lcsh:Pharmacy and materia medica 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Equivalence test medicine Statistical analysis 0101 mathematics Equivalence (measure theory) Administration of drugs Mathematics batch effect Fieller's confidence interval Guideline Confidence interval Cortisone Reference product Estudi de casos Cortisona equivalence test Fieller’s confidence interval Betamethasone Administració de medicaments Case studies multiple quality variables medicine.drug |
| Zdroj: | Pharmaceutics, Vol 12, Iss 318, p 318 (2020) Dipòsit Digital de la UB Universidad de Barcelona Pharmaceutics Volume 12 Issue 4 |
| ISSN: | 1999-4923 |
| Popis: | This study examines the statistical implications, and their possible implementation, of the &ldquo Draft guideline on quality and equivalence of topical products&rdquo 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: | OpenAIRE |
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