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See detailDevelopment, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops.
Mbinze Kidenge, Jérémie; Sacre, Pierre-Yves ULg; Yemoa, Achille et al

in Journal of Pharmaceutical & Biomedical Analysis (2015), 111

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient ... [more ▼]

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient local drug analysis laboratories. To tackle part of this issue, two spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in children’s oral drops formulations were developed and validated. Raman and Near Infrared (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive and rapid characteristics. Both of the methods developed were successfully validated using the total error approach in the range of 50-150% of the target concentration (20% W/V) within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market were analyzed by both techniques to detect potentially substandard drugs. After a comparison of the analytical performance of both methods, it has been decided to implement the method based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the Quality Control Laboratory of Drugs at the University of Kinshasa (DRC). [less ▲]

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See detailFalsification des médicaments: Est-il possible d'améliorer la puissance des outils de détection ?
Ziemons, Eric ULg; Sacre, Pierre-Yves ULg; Marini Djang'Eing'A, Roland ULg et al

Conference given outside the academic context (2015)

La mise sur le marché de médicaments falsifiés est une réalité dont on imagine rarement l’importance et la nuisance : on estime pourtant que ce marché rapporte plus que le trafic de drogue et il arrive ... [more ▼]

La mise sur le marché de médicaments falsifiés est une réalité dont on imagine rarement l’importance et la nuisance : on estime pourtant que ce marché rapporte plus que le trafic de drogue et il arrive que localement, des produits falsifiés soient plus nombreux que les produits originaux (cas des anti-malariques au Congo). La lutte contre la falsification s’est d’abord focalisée sur les emballages et les identificateurs tels que les codes-barres, qui aujourd’hui ne garantissent plus le contenu du médicament vu les progrès réalisés par les organisations criminelles en matière de reproduction d’emballage. La solution sûre consiste donc à analyser, sur place, la composition du produit à travers l’emballage et à comparer le résultat à la «carte d’identité» du médicament établie par le producteur. Les besoins portent donc sur des instruments d’analyse portables et capables de dialoguer à distance avec des banques de données de «cartes d’identité». Ceux-ci requièrent une approche pluridisciplinaire impliquant notamment des micro-électroniciens et des informaticiens. [less ▲]

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See detailEstimation of the Time Interval between the Administration of Heroin and the Sampling of Blood in Chronic Inhalers
DUBOIS, Nathalie ULg; HALLET, Claude ULg; SEIDEL, Laurence ULg et al

in Journal of Analytical Toxicology (2015)

To develop a model for estimating the time delay between last heroin consumption and blood sampling in chronic drug users. Eleven patients, all heroin inhalers undergoing detoxification, were included in ... [more ▼]

To develop a model for estimating the time delay between last heroin consumption and blood sampling in chronic drug users. Eleven patients, all heroin inhalers undergoing detoxification, were included in the study. Several plasma samples were collected during the detoxification procedure and analyzed for the heroin metabolites 6-acetylmorphine (6AM), morphine (MOR), morphine-6-glucuronide (M6G) and morphine-3-glucuronide (M3G), according to a UHPLC/MSMS method. The general linear mixed model was applied to time-related concentrations and a pragmatic four-step delay estimation approach was proposed based on the simultaneous presence of metabolites in plasma. Validation of the model was carried out using the jackknife technique on the 11 patients, and on a group of 7 test patients. Quadratic equations were derived for all metabolites except 6AM. The interval delay estimation was 2–4 days when only M3G present in plasma, 1–2 days when M6G and M3G were both present, 0–1 day when MOR, M6G and M3G were present and <2 h for all metabolites present. The ‘jackknife’ correlation between declared and actual estimated delays was 0.90. The overall precision of the delay estimates was 8–9 h. The delay between last heroin consumption and blood sampling in chronic drug users can be satisfactorily predicted from plasma heroin metabolites. [less ▲]

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See detailIntroduction à l’incertitude de mesure - Partim 2
Marini Djang'Eing'A, Roland ULg; Vermaercke, Peter; Hubert, Philippe ULg

Learning material (2015)

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See detailIntroduction à l’incertitude de mesure - Partim 1
Marini Djang'Eing'A, Roland ULg; Vermaercke, Peter; Hubert, Philippe ULg

Learning material (2015)

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See detailTotal Error-Based Validation Including the Experimental Design-Based Robustness Evaluation of a Stability-Indicating Method for the Simultaneous Quantification of Hydrochlorothiazide and Valsartan in Tablet Formulations
ELKARBANE, M; AMOOD AL-KAMARANY, M; BOUCHAFRA, H et al

in Acta Chromatographica (2015), 27(2), 1-20

A gradient reversed phase high-performance liquid chromatography (RPHPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet ... [more ▼]

A gradient reversed phase high-performance liquid chromatography (RPHPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet formulation during forced degradation studies was developed. This method was validated using a novel approach, namely, the accuracy profile or total errors approach. The robustness of the method was evaluated using a Plackett–Burman design for eight factors. The algorithm of Dong was applied to determine the significant factor effects. The validation results showed that the method is precise (RSD: 1.14% for HCT and 0.43% for VS) and accurate (mean recovery: 99.90% for HCT and 99.98% for VS). On the other hand, the results of the robustness study showed that the type of column was the important factor which affects a number of responses, namely, the asymmetry factor (AF), retention time (RT), and resolution (RS). However, the assay results were not affected; therefore, the method can be considered robust. Finally, the method was applied to study the stability of HCT and VS under forced conditions. Significant results were obtained with basic hydrolysis, oxidation, and thermal stress, while the accelerated and acidic conditions did not affect the stability of HCT or VS. [less ▲]

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See detailAPPUI ANALYTIQUE A LA LUTTE CONTRE LES MEDICAMENTS DE QUALITE INFERIEURE
Mbinze Kindenge, Jérémie; Hubert, Philippe ULg; Marini Djang'Eing'A, Roland ULg

Conference (2015, January 27)

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See detailDesign Space for Analytical Methods: Why ? What ? How ?
Rozet, Eric ULg; Debrus, Benjamin ULg; Lebrun, Pierre ULg et al

Conference (2015, January 22)

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See detailFighting Poor Quality Medicines: Develop-ment, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Mbinze Kindenge, Jérémie; Yemoa, Achille; Lebrun, Pierre ULg et al

in American Journal of Analytical Chemistry (2015), 6

As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative ... [more ▼]

As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative techniques. In this study, a generic liquid chromatographic method was firstly devel-oped for the purpose of screening 8 antimalarial active ingredients, namely amodiaquine (AQ), piperaquine (PPQ), sulfalene (SL), pyrimethamine (PM), lumefantrine (LF), artesunate (AS), artemether (AM) and dihydroartemisinine (DHA) by applying DoE/DS optimization strategy. Since the method was not totally satisfying in terms of peak separation, further experiments were undergone applying the same development strategy while splitting the 8 ingredients into five groups. Excellent prediction was observed prior to correlation between retention times of predicted and observed separation conditions. Then, a successful geometric transfer was realized to reduce the analysis time focusing on the simultaneous quantification of two WHO's recommended ACTs in anti-malarial fixed-dose combination (AM-LF and AS-AQ) in tablets. The optimal separation was achieved using an isocratic elution of methanol-ammonium formate buffer (pH 2.8; 10mM) (82.5: 17.5, v/v) at 0.6ml/min through a C18 column (100mm×3.5mm, 3.5 μm) thermostated at 25°C. After a successful validation stage based on the total error approach, the method was applied to determine the content of AM/LF or AS/AQ in seven brands of antimalarial tablets currently marketed in West, Central and East Africa. Satisfying results were obtained compared to the claimed contents. [less ▲]

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See detailApplication of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines
Mbinze, Kingenge; Nsangu Mpasi, Jean; Maghe, Elza et al

in American Journal of Analytical Chemistry (2015), 6

In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric ... [more ▼]

In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2-10µg/mL (for quinine sulfate in tablet), 4-12µg/mL (for quinine bichlorhydrate in oral drop - metronidazole benzaote in oral suspension) and 15-35µg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms. [less ▲]

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See detailTowards a full integration of optimization and validation phases: An Analytical-Quality-by-Design approach
Hubert, Cédric ULg; Houari, Sabah ULg; Rozet, Eric ULg et al

in Journal of Chromatography. A (2015)

When using an analytical method, defining an Analytical Target Profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context ... [more ▼]

When using an analytical method, defining an Analytical Target Profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context, two case studies were selected in order to demonstrate the potential of a Quality-by-Design (QbD) strategy when applied to two specific phases of the method lifecycle: the pre-validation study and the validation step. The first case study focused on the improvement of a Liquid Chromatography (LC) coupled to Mass Spectrometry (MS) stability-indicating method by the means of the QbD concept. The Design of Experiments (DoE) conducted during the optimization step (i.e. determination of the qualitative Design Space (DS)) was performed a posteriori. Additional experiments were performed in order to simultaneously conduct the pre-validation study to assist in defining the DoE to be conducted during the formal validation step. This predicted protocol was compared to the one used during the formal validation. A second case study based on the LC/MS-MS determination of glucosamine and galactosamine in human plasma was considered in order to illustrate an innovative strategy allowing the QbD methodology to be incorporated during the validation phase. An operational space, defined by the qualitative DS, was considered during the validation process rather than a specific set of working conditions as conventionally performed. Results of all the validation parameters conventionally studied were compared to those obtained with this innovative approach for glucosamine and galactosamine. Using this strategy, qualitative and quantitative information were obtained. Consequently, an analyst using this approach would be able to select with great confidence several working conditions within the operational space rather than a given condition for the routine use of the method. This innovative strategy combines both a learning process and a thorough assessment of the risk involved. [less ▲]

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