Reference : Methodology for the Validation of Analytical Methods involved in Uniformity of Dosage...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/133445
Methodology for the Validation of Analytical Methods involved in Uniformity of Dosage Units tests
English
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, Bruno []
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2013
Analytica Chimica Acta
Elsevier
760
46-52
Yes (verified by ORBi)
International
0003-2670
1873-4324
Amsterdam
The Netherlands
[en] Quality by Design ; tolerance intervals ; fit for purpose ; content uniformity ; uniformity of dosage units ; Analytical Target Profile
[en] Validation of analytical methods is required prior to their routine use. In addition, the current implementation of the Quality by Design (QbD) framework in the pharmaceutical industries aims at improving the quality of the end products starting from its early design stage. However, no regulatory guideline or none of the published methodologies to assess method validation propose decision methodologies that effectively take into account the final purpose of developed analytical methods. In this work a solution is proposed for the specific case of validating analytical methods involved in the assessment of the Content Uniformity or Uniformity of Dosage Units of a batch of pharmaceutical drug products as proposed in the European or US pharmacopoeias. This methodology uses statistical tolerance intervals as decision tools. Moreover it adequately defines the Analytical Target Profile of analytical methods in order to obtain analytical methods that allow to make correct decisions about Content Uniformity or Uniformity of Dosage Units with high probability. The applicability of the proposed methodology is further illustrated using an HPLC-UV assay as well as a Near Infra-Red Spectrophotometric method.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/133445

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