References of "Hubert, Cédric"
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See detailImprovement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: A case of a learning process
Hubert, Cédric ULg; Lebrun, Pierre ULg; Houari, Sabah ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 88

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a ... [more ▼]

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by-Design (QbD) methodology based on a Design of Experiments (DoE) approach was evaluated within the framework of a Liquid Chromatography (LC) method. This approach allows the investigation of Critical Process Parameters (CPPs), which have an impact on Critical Quality Attributes (CQAs) and, consequently, on LC selectivity. Using polynomial regression response modeling as well as Monte Carlo simulations for error propagation, Design Space (DS) was computed in order to determine robust working conditions for the developed stability-indicating method. This QbD compliant development was conducted in two phases allowing the use of the Design Space knowledge acquired during the first phase to define the experimental domain of the second phase, which constitutes a learning process. The selected working condition was then fully validated using accuracy profiles based on statistical tolerance intervals in order to evaluate the reliability of the results generated by this LC/ESI-MS stability-indicating method. A comparison was made between the traditional Quality-by-Testing (QbT) approach and the QbD strategy, highlighting the benefit of this QbD strategy in the case of an unexpected impurities issue. On this basis, the advantages of a systematic use of the QbD methodology were discussed. [less ▲]

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See detailUsefulness of capability indices in the framework of analytical methods validation
Bouabidi, Abderrahim ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytica Chimica Acta (2012), 714

Analytical methods capability evaluation can be a useful methodology to assess the fitness of purpose of these methods for their future routine application. However, care on how to compute the capability ... [more ▼]

Analytical methods capability evaluation can be a useful methodology to assess the fitness of purpose of these methods for their future routine application. However, care on how to compute the capability indices has to be made. Indeed, the commonly used formulas to compute capability indices such as Cpk, will highly overestimate the true capability of the methods. Especially during methods validation or transfer, there are only few experiments performed and, using in these situations the commonly applied capability indices to declare a method as valid or as transferable to a receiving laboratory will conduct to inadequate decisions. In this work, an improved capability index, namely Cpk-tol and the corresponding estimator of proportion of non conforming results ( ) has been proposed. Through Monte-Carlo simulations, they have been shown to greatly increase the estimation of analytical methods capability in particular in low sample size situations as encountered during methods validation or transfer. Additionally, the usefulness of this capability index has been illustrated through several case studies covering applications commonly encountered in the pharmaceutical industry. Finally a methodology to determine the optimal sample size required to validate analytical methods is also given using the proposed capability metric. [less ▲]

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See detailHigh Throughput determination of Levonorgestrel in human plasma using a Sensitive LC-MS/MS method
Hubert, Cédric ULg; Streel, Bruno; Sibenaler, Renilde et al

Poster (2011, June 19)

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See detailProtocole d'essai LC/MS - P001 - V01
Hubert, Cédric ULg; Ziemons, Eric ULg; Hubert, Philippe ULg

Report (2011)

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See detailComparison between new and old excipients
Hubert, Cédric ULg; Ziemons, Eric ULg; Hubert, Philippe ULg

Report (2011)

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See detailTOLERANCE INTERVALS AS CONTROL CHART: COMPARISON TO CLASSIC SHEWHART X̅-R CONTROL CHART
Marini Djang'Eing'A, Roland ULg; Lambert, Véronique; Denooz, Raphael ULg et al

Poster (2010, September)

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See detailEstimation of uncertainty from the total error strategy: Application to internal and normative methods
Marini Djang'Eing'A, Roland ULg; Rozet, Eric ULg; Hubert, Cédric ULg et al

in Acta Clinica Belgica (2010), 65

Based on the importance of uncertainty, another approach to estimate this parameter of performance considering the total error (systematic and random) was applied. The data were obtained from the two main ... [more ▼]

Based on the importance of uncertainty, another approach to estimate this parameter of performance considering the total error (systematic and random) was applied. The data were obtained from the two main steps of an analytical method lifecycle: validation and routine for levonorgestrel (LNG) assay and routine for oxygen assay. Results obtained allowed drawing suitable conclusion in terms of prediction of routine and establishment of norms. [less ▲]

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