Reference : DO PLACEBO BASED VALIDATION STANDARDS MIMIC REAL BATCH PRODUCTS BEHAVIOUR? CASE STUDIES
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/85024
DO PLACEBO BASED VALIDATION STANDARDS MIMIC REAL BATCH PRODUCTS BEHAVIOUR? CASE STUDIES
English
Bouabidi, A. [ > > ]
Talbi, M. [ > > ]
Bouklouze, A. [ > > ]
El Karbane, M. [ > > ]
Bourichi, H. [ > > ]
El Guezzar, M. [ > > ]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2011
Journal of Pharmaceutical & Biomedical Analysis
Elsevier Science
55
583-590
Yes (verified by ORBi)
International
0731-7085
Oxford
United Kingdom
[en] Authentic batch sample ; Placebo validation standards ; validation methodology ; accuracy profile ; reconstituted validation standard
[en] Analytical methods validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application. Validation usually involves validation standards or quality control samples that are prepared in placebo or reconstituted matrix made of a mixture of all the ingredients composing the drug product except the active substance or the analyte under investigation. However, one of the main concerns that can be made with this approach is that it may lack an important source of variability that come from the manufacturing process. The question that remains at the end of the validation step is about the transferability of the quantitative performance from validation standards to real authentic drug product samples.
In this work, this topic is investigated through three case studies. Three analytical methods were validated using the commonly spiked placebo validation standards at several concentration levels as well as using samples coming from authentic batch samples (tablets and syrups). The results showed that, depending on the type of response function used as calibration curve, there were various degrees of differences in the results accuracy obtained with the two types of samples. Nonetheless the use of spiked placebo validation standards was showed to mimic relatively well the quantitative behaviour of the analytical methods with authentic batch samples. Adding these authentic batch samples into the validation design may help the analyst to select and confirm the most fit for purpose calibration curve and thus increase the accuracy and reliability of the results generated by the method in routine application.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/85024

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