Exploratory data analysis methods for comparison of drug dissolution profiles

• Autorzy: Enăchescu C.
• Języki publikacji: EN

Abstrakty

EN

A new approach for 'similarity' testing through comparison of drug products dissolution profiles, based on multivariate data analysis is presented. The dissolution curves corresponding to three products containing oxicams (piroxicam, meloxicam and tenoxicam) as oral solid dosage forms were obtained by dissolution tests at multiple pre-specified time points and in different compendial media. Dissolution data was simultaneously subjected to principal component and cluster analysis and comparisons between the dissolution characteristics of different products were carried out. All the results were compared with information provided by the difference (f1) and similarity (f2) factor tests. Unlike the f2 criterion, the proposed methods reflect variability within the individual dissolution curves, being also highly sensitive to profile variations.

Słowa kluczowe

EN

multivariate data analysis; drug products; dissolution profiles; principal component analysis; cluster analysis; oxicams

PL

zmienna; analiza danych; lekarstwo; profil rozpuszczalności; analiza składników głównych; analiza skupień; oksykam

• Wydawca: Nałęcz Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of Sciences ; Elsevier
• Czasopismo: Biocybernetics and Biomedical Engineering
• Rocznik: 2010
• Tom: Vol. 30, no. 4
• Strony: 17--27
• Opis fizyczny: Bibliogr. 7 poz., rys., tab., wykr.

Twórcy

autor

Enăchescu C.

• University of Bucharest, Faculty of Mathematics and Computer Science, str. Academiei 14, Bucharest 010014, Romania,

Bibliografia

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• 5. FDA 2000: Guidance for Industry, Waiver of in Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. FDA/CDER,Washington, DC.
• 6. Enachescu D.: Data mining. Methods and Applications (in romanian). Ed. Academiei, Bucureşti 2009.
• 7. Rinaki E., Dokoumetzidis A., Macheras P.: The mean dissolution time depends on dose/solubility ratio. Pharm. Res. 2003, 20, 406-408.