References of "Marini Djang'Eing'A, Roland"
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See detailFalsification des médicaments: mythe ou réalité ?
Marini Djang'Eing'A, Roland ULg; Fillet, Marianne ULg; Vancauwenberghe, Roy et al

Conference (2013, April 24)

La santé publique est de nos jours minée par la problématique des médicaments falsifiés ou de qualité inférieure, avec plusieurs conséquences sanitaires, économiques voire professionnelles. On estime à 7 ... [more ▼]

La santé publique est de nos jours minée par la problématique des médicaments falsifiés ou de qualité inférieure, avec plusieurs conséquences sanitaires, économiques voire professionnelles. On estime à 7% la part du marché pharmaceutique mondial que représenterait ce fléau; l’Afrique, l’Asie et de nombreux pays d'Amérique latine étant les régions les plus touchées avec plus de 30% de médicaments falsifiés. D’après l'OMS, plus de 50% des médicaments achetés à partir des sites internet illégaux sont contrefaits, annihilant très fortement les chances de succès thérapeutique. Ces médicaments viennent dans la plupart des cas des pays asiatiques et de l’Eurasie. Le trafic de faux médicaments est un crime contre l'humanité qui représente environ 50 milliards de dollars par an (10-15 % de plus que le marché de la drogue). Au travers de deux leçons, la situation de la falsification des médicaments sera présentée au grand public dans le but de le sensibiliser à ce fléau. La première leçon présentera la situation en Europe avec un accent sur la Belgique. La problématique du droit à la propriété intellectuelle et de l’encadrement législatif sera abordée, ainsi que la falsification des médicaments modernes et des phytomédicaments, ces derniers étant utilisés par plus de 40% de la population en Europe et aux Etats-Unis. Dans la seconde leçon sera abordée la situation vécue en Afrique. L’approvisionnement en médicaments de qualité par le partage de l’information sera présenté ainsi que les moyens analytiques à la disposition de ce continent pour combattre ce fléau. Des membres du Département de Pharmacie de l’Université de Liège, de l’Agence Fédérale des Médicaments et des Produits de Santé ainsi que du programme QUAMED (Quality Medicines for All) feront partager leur expérience sur cette question d’une brûlante actualité.  [less ▲]

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See detailBlood lead, urinary lead, urinary δ-aminolevulinic acid and urinary porphyrins levels among people living in kinshasa, D.R. Congo : a pilot biomonitoring study
Mputu Malolo, Corneille-Liévin; Ndelo di Phanzu, Josaphat; Marini Djang'Eing'A, Roland ULg et al

in Acta Clinica Belgica (2013), 68(6), 475

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See detailUsefulness of Information Criteria for the Selection of Calibration Curves
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytical Chemistry (2013), 85

The reliability of analytical results obtained with quantitative analytical methods is highly dependant upon the selection of the adequate model used as calibration curve. To select the adequate response ... [more ▼]

The reliability of analytical results obtained with quantitative analytical methods is highly dependant upon the selection of the adequate model used as calibration curve. To select the adequate response function or model the most used and known parameter is the determination coefficient R². However it is well known that it suffers many inconvenient, such as leading to overfitting the data. A solution proposed is to use the adjusted determination coefficient R²adj that aims at reducing this problem. However there is another family of criteria that exists to allow the selection of an adequate model: the information criteria AIC, AICc and BIC. These criteria have rarely been used in analytical chemistry to select the adequate calibration curve. This works aims at assessing the performance of the statistical information criteria as well as R² and R²adj for the selection of an adequate calibration curve. They are applied to several analytical methods covering liquid chromatographic methods as well as electrophoretic ones involved in the analysis of active substances in biological fluids or aimed at quantifying impurities in drug substances. In addition, Monte-Carlo simulations are performed to assess the efficacy of these statistical criteria to select the adequate calibration curve. [less ▲]

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See detailMethodology for the Validation of Analytical Methods involved in Uniformity of Dosage Units tests
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytica Chimica Acta (2013), 760

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 ... [more ▼]

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. [less ▲]

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See detailIntérêt de la microscopie vibrationnelle dans la recherche de nouvelles formulations pharma-ceutiques à haute valeur ajoutée.
Sacre, Pierre-Yves ULg; Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg et al

Report (2012)

La grande majorité des nouvelles molécules actives présente une faible biodisponibilité dans des formulations pharmaceutiques simples contenant principalement un ou plusieurs constituants et l’actif ... [more ▼]

La grande majorité des nouvelles molécules actives présente une faible biodisponibilité dans des formulations pharmaceutiques simples contenant principalement un ou plusieurs constituants et l’actif faiblement soluble dans l’eau. Dès lors, il est primordial d’investir dans la recherche de nouvelles formulations « plus sophistiquées » (formulations de demain) favorisant la solubilité de l’actif. Cependant cette recherche est limitée par celle de nouveaux outils analytiques pointus permettant de les caractériser, d’étudier les interactions au sein des formulations pharmaceutiques, de comprendre les mécanismes liès à leur formation et in fine de contrôler et garantir leur conformité. Par ailleurs, la Technologie Analytique des Procédés (PAT) est un concept développé par l’Administration Américaine des Aliments et des Médicaments (FDA) et soutenu par l’Agence Européenne des Médicaments (EMA). Ce concept qui devient de plus en plus incontournable (au niveau des dossiers d’Autorisation de Mise sur le Marché). La rapidité de mesure et le caractère non destructif de la spectroscopie vibrationnelle dont fait partie la microscopie Raman la rendent particulièrement compatibles avec ce concept. De plus, les techniques vibrationnelles de part l’absence de préparation de l’échantillon et de l’utilisation de solvant organique rencontrent également le concept de Chimie Verte et donc s’incrivent parfaitement dans un contexte de développement durable et respectueux de l’environnement. L’objectif du présent projet est d’explorer les potentialités de la microscopie Raman dans l’étude pointue des matrices complexes afin d’en améliorer les connaissances tant au niveau de leur charactérisation, des intéractions analyte-matrice que des mécanismes liés à leur formation. L’obtention de ces informations nécéssiteront la recherche de nouvelles méthodologies, outils et règles de décision dédicacés aux aspects qualitatifs et plus encore aux aspects quantiftatifs où l’accès à de telles données est très marginal. L’ensemble de cette recherche sera réalisée sur un modèle complexe, une formulation à haute valeur ajoutée issue de l’industrie pharmaceutique. [less ▲]

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See detailModèles statistiques Bayésiens et méthodologies pour calculer le Design Space (OPTIMAL-DS)
Marini Djang'Eing'A, Roland ULg; Lebrun, Pierre ULg; Hubert, Philippe ULg

Report (2012)

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de ... [more ▼]

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de conduites initiées par la FDA ou d'autres organismes de contrôles. Notamment, le document ICH Q8 introduit les notions de "Process Analytical Technology", de "Quality by Design" et de "Design Space", ayant attraits à la qualité des procédés industriels, des procédés d'analyse ainsi qu'à la qualité des produits finis. Cependant, si les lignes de conduites pour ces exigences sont expliquées, aucune méthodologie pour les atteindre n'est donnée. Or, un nombre considérable de nouvelles entités chimiques sont synthétisées par les laboratoires pharmaceutiques, biotechnologiques ou agroalimentaires. Les producteurs de matières premières et/ou d’excipients (secteur chimique) ont également besoin de disposer rapidement de méthodes analytiques de contrôle qui leur permettront de s’assurer de la qualité de leurs produits. On comprend aisément la nécessité pour ces secteurs de disposer rapidement de résultats fiables puisque les activités de recherches mais aussi des investissements, souvent importants, sont orientés ou stoppés sur base de données chiffrées, produits par les méthodes analytiques. La production de résultats fiables et la démonstration de cette fiabilité sont donc économiquement fondamentales. Ce projet vise la mise au point de stratégies et de modèles génériques de développement automatisé de nouvelles méthodes analytiques séparatives, en se basant sur la modélisation des temps de rétention, la planification expérimentale, et le concept de Design Space. L’objectif connexe est d’appliquer cette méthodologie à l’optimisation de n’importe quel procédé. Le fait de pouvoir disposer d’une méthodologie de mise au point automatique de méthodes analytiques ou de tous procédés analytiques aura un impact significatif. Cette nouvelle technologie permettra de réduire de façon drastique le temps d’optimisation des méthodes et procédés, permettant une production plus efficiente de produits (pharmaceutique, cosmétique, agro-alimentaire ou biotechnologique) répondant aux spécifications du client. [less ▲]

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See detailAPPLICATION OF AN INNOVATIVE DESIGN SPACE OPTIMIZATION STRATEGY TO THE DEVELOPMENT OF LC METHODS TO COMBAT POTENTIALLY COUNTERFEIT NONSTEROIDAL ANTIINFLAMMATORY DRUGS
Mbinze Kindenge, Jérémie ULg; Lebrun, Pierre ULg; Debrus, Benjamin ULg et al

in Journal of Chromatography. A (2012), 1263

In the context of the battle against counterfeit medicines, an innovative methodology has been used to develop rapid and specific high performance liquid chromatographic methods to detect and determine 18 ... [more ▼]

In the context of the battle against counterfeit medicines, an innovative methodology has been used to develop rapid and specific high performance liquid chromatographic methods to detect and determine 18 non-steroidal anti-inflammatory drugs, 5 pharmaceutical conservatives, paracetamol, chlorzoxazone, caffeine and salicylic acid. These molecules are commonly encountered alone or in combination on the market. Regrettably, a significant proportion of these consumed medicines are counterfeit or substandard, with a strong negative impact in countries of Central Africa. In this context, an innovative design space optimization strategy was successfully applied to the development of LC screening methods allowing the detection of substandard or counterfeit medicines. Using the results of a unique experimental design, the design spaces of 5 potentially relevant HPLC methods have been developed, and transferred to an ultra high performance liquid chromatographic system to evaluate the robustness of the predicted DS while providing rapid methods of analysis. Moreover, one of the methods has been fully validated using the accuracy profile as decision tool, and was then used for the quantitative determination of three active ingredients and one impurity in a common and widely used pharmaceutical formulation. The method was applied to 5 pharmaceuticals sold in the Democratic Republic of Congo. None of these pharmaceuticals was found compliant to the European Medicines Agency specifications [less ▲]

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See detailDevelopment of a generic micellar electrokinetic chromatography method for the separation of 15 antimalarial drugs as a tool to detect medicine counterfeiting
Lamalle, Caroline ULg; Marini Djang'Eing'A, Roland ULg; Debrus, Benjamin ULg et al

in Electrophoresis (2012), 33

Since antimalarial drugs counterfeiting is dramatically present on the African market, the development of simple analytical methods for their quality control is of great importance. This work consists in ... [more ▼]

Since antimalarial drugs counterfeiting is dramatically present on the African market, the development of simple analytical methods for their quality control is of great importance. This work consists in the CE analysis of 15 antimalarials (artesunate, artemether, amodiaquine, chloroquine, piperaquine, primaquine, quinine, cinchonine, mefloquine, halofantrine, sulfadoxine, sulfalen, atovaquone, proguanil, and pyrimethamine). Since all these molecules cannot be ionized at the same pH, MEKC was preferred because it also allows separation of neutral compounds. Preliminary experiments were first carried out to select the most crucial factors affecting the antimalarials separation. Several conditions were tested and four parameters as well as their investigation domain were chosen: pH (5–10), SDS concentration (20–90 mM), ACN proportion (10–40%), and temperature (20–35°C). Then, the experimental design methodology was used and a central composite design was selected. Mathematical modeling of the migration times allowed the prediction of optimal conditions (29°C, pH 6.6, 29 mM SDS, 36% ACN) regarding analyte separation. The prediction at this optimum was verified experimentally and led to the separation of 13 compounds within 8 min. Finally, the method was successfully applied to the quality control of African antimalarial medicines for their qualitative and quantitative content. [less ▲]

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See detailQUALITY ASSESSMENT OF MEDICINES MARKETED IN RWANDA, July-Oct. 2011
Habyalimana, Védaste; Mbinze Kindenge, Jérémie; Kadima Ntokamunda, Justin Léonard et al

Scientific conference (2012, July)

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See detailDEVELOPMENT AND VALIDATION OF A LC-UV METHOD FOR THE DOSAGE OF A TRACER IN AN IMPROVED TRADITIONAL MEDICINE
Tshisekedi Tshibangu, Pascal; Kalenda Dibungi T., Pascal; Wauters, Jean-Noël ULg et al

Conference (2012, July)

According to World Health Organisation, 80% of the African populations use Improved Traditional Medicines (ITM) to threat several diseases. Even if some of these ITM are nowadays registered with local ... [more ▼]

According to World Health Organisation, 80% of the African populations use Improved Traditional Medicines (ITM) to threat several diseases. Even if some of these ITM are nowadays registered with local health authorities, the knowledge of their qualitative and quantitative composition still remains a challenge for ensuring health security of populations. In this context, an analytical method using liquid chromatography technique with UV detection was developed to allow the dosage of a tracer (major compound) in an ITM (syrup containing extract plants) registered in D.R. Congo by the “Centre de Recherche en Médecine Traditionnelle Améliorée” and marketed for use against malaria. For that purpose, a simple and rapid experimental plan considering a Plackett-Burman design was applied by testing simultaneously two significant factors, temperature of analytical column (T°) and gradient time (TG) for eluting acetonitrile (ACN) from 5% to 95%, while focusing on the separation of the tracer and an adjacent unknown compound (critical peak pairs). Suitable separation (resolution of 1.5) was obtained between these latter with T° of 15°C and TG of 60 min (20% to 65% of ACN). Prior to routine use, the analytical method was validated following the total error strategy described by the SFSTP guidelines and according to the ISO norm 17025:2005. Specificity/selectivity of the method was demonstrated by the absence of interference at the retention time of the major compound comparing to the syrup matrix. Very interesting results were observed for trueness (relative biases below 0.9%), for precision (RSD mostly below 2.2% for repeatability and time-different intermediate precision), for accuracy (beta tolerance intervals below 10% of the acceptance limits) and linearity. Finally, the method was applied to quantify the major compound in several batches of syrups ITM as well as for stability studies. [less ▲]

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See detailModèles statistiques Bayésiens et méthodologies pour calculer le Design Space (OPTIMAL-DS)
Marini Djang'Eing'A, Roland ULg; Lebrun, Pierre ULg; Rozet, Eric ULg et al

Report (2012)

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de ... [more ▼]

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de conduites initiées par la FDA ou d'autres organismes de contrôles. Notamment, le document ICH Q8 introduit les notions de "Process Analytical Technology", de "Quality by Design" et de "Design Space", ayant attraits à la qualité des procédés industriels, des procédés d'analyse ainsi qu'à la qualité des produits finis. Cependant, si les lignes de conduites pour ces exigences sont expliquées, aucune méthodologie pour les atteindre n'est donnée. Or, un nombre considérable de nouvelles entités chimiques sont synthétisées par les laboratoires pharmaceutiques, biotechnologiques ou agroalimentaires. Les producteurs de matières premières et/ou d’excipients (secteur chimique) ont également besoin de disposer rapidement de méthodes analytiques de contrôle qui leur permettront de s’assurer de la qualité de leurs produits. On comprend aisément la nécessité pour ces secteurs de disposer rapidement de résultats fiables puisque les activités de recherches mais aussi des investissements, souvent importants, sont orientés ou stoppés sur base de données chiffrées, produits par les méthodes analytiques. La production de résultats fiables et la démonstration de cette fiabilité sont donc économiquement fondamentales. Ce projet vise la mise au point de stratégies et de modèles génériques de développement automatisé de nouvelles méthodes analytiques séparatives, en se basant sur la modélisation des temps de rétention, la planification expérimentale, et le concept de Design Space. L’objectif connexe est d’appliquer cette méthodologie à l’optimisation de n’importe quel procédé. Le fait de pouvoir disposer d’une méthodologie de mise au point automatique de méthodes analytiques ou de tous procédés analytiques aura un impact significatif. Cette nouvelle technologie permettra de réduire de façon drastique le temps d’optimisation des méthodes et procédés, permettant une production plus efficiente de produits (pharmaceutique, cosmétique, agro-alimentaire ou biotechnologique) répondant aux spécifications du client. [less ▲]

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See detailLA FALSIFICATION DES MEDICAMENTS
Marini Djang'Eing'A, Roland ULg

in Forum Pharmaceutique (2012, March 16), -(-), 16

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See detailSMALL SAMPLE SIZE CAPABILITY INDEX FOR ASSESSING VALIDITY OF ANALYTICAL METHODS
Rozet, Eric ULg; Boulanger, B.; Ziemons, Eric ULg et al

Poster (2012, March)

Analytical method’s 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 method’s 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 (tolCpk−π) is 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 is illustrated through several case studies. [less ▲]

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See detailComments on “Uncertainty profiles for the validation of analytical methods” by Saffaj and Ihssane
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Talanta (2012), 88

Saffaj et al., recently proposed an uncertainty profile for evaluating the validity of analytical methods using the statistical methodology of γ-confidence β-content tolerance intervals. This profile ... [more ▼]

Saffaj et al., recently proposed an uncertainty profile for evaluating the validity of analytical methods using the statistical methodology of γ-confidence β-content tolerance intervals. This profile assesses the validity of the method by comparing the method measurement uncertainty to a pre defined acceptance limit stating the maximum uncertainty suitable for the method under study. Several years earlier as stated by these authors a SFSTP (Société Française des Sciences et Techniques Pharmaceutique) commission has developed a similar profile called accuracy profile used to assess the validity of analytical methods. This accuracy profile also uses the methodology of statistical tolerance intervals, but β-expectation tolerance intervals. The uncertainty profile of Saffaj et al. and the accuracy profile of the SFSTP commission are both fulfilling the same final purpose. The core question is finally what statistical tolerance interval to use ? The aim of this letter to the editor is to discuss this question and provide arguments that β-expectation tolerance intervals should be prefered to assess the validity of the method as this type of interval give the guarantee that each future results has high probability to fall within pre-specified acceptance limits. [less ▲]

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See detailReply to the responses on the comments on “Uncertainty profiles for the validation of analytical methods” by Saffaj and Ihssane
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Talanta (2012), 100

Saffaj et al., recently proposed an uncertainty profile for evaluating the validity of analytical methods using the statistical methodology of γ-confidence β-content tolerance intervals. This profile ... [more ▼]

Saffaj et al., recently proposed an uncertainty profile for evaluating the validity of analytical methods using the statistical methodology of γ-confidence β-content tolerance intervals. This profile assesses the validity of the method by comparing the method measurement uncertainty to a pre defined acceptance limit stating the maximum uncertainty suitable for the method under study. In this letter we comment on the response (T. Saffaj, B. Ihssane, Talanta 94 (2012) 361-362) these authors have made to our previous letter (E. Rozet, E. Ziemons, R.D. Marini, B. Boulanger, Ph. Hubert, Talanta 88 (2012) 769–771). In particular, we demonstrate that β-expectation tolerance intervals are prediction intervals, we show that β-expectation tolerance intervals are highly usefull for assessing analytical methods validation and for estimating measurement uncertainty and finally we show what are the differences and implications for these two topics (validation and uncertainty) when using either the methodology of β-expectation tolerance intervals or the γ-confidence β-content tolerance tolerance interval one. [less ▲]

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See detailValidation of analytical methods involved in dissolution assays: Acceptance limits and decision methodologies
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytica Chimica Acta (2012), 751

Dissolution tests are key elements to ensure continuing product quality and performance. The ultimate goal of these tests is to assure consistent product quality within a defined set of specification ... [more ▼]

Dissolution tests are key elements to ensure continuing product quality and performance. The ultimate goal of these tests is to assure consistent product quality within a defined set of specification criteria. Validation of an analytical method aimed at assessing the dissolution profile of products or at verifying pharmacopoeias compliance should demonstrate that this analytical method is able to correctly declare two dissolution profiles as similar or drug products as compliant with respect to their specifications. It is essential to ensure that these analytical methods are fit for their purpose. Method validation is aimed at providing this guarantee. However, even in the ICHQ2 guideline there is no information explaining how to decide whether the method under validation is valid for its final purpose or not. Are the entire validation criterion needed to ensure that a Quality Control (QC) analytical method for dissolution test is valid? What acceptance limits should be set on these criteria? How to decide about method’s validity? These are the questions that this work aims at answering. Focus is made to comply with the current implementation of the Quality by Design (QbD) principles in the pharmaceutical industry in order to allow to correctly defining the Analytical Target Profile (ATP) of analytical methods involved in dissolution tests. Analytical method validation is then the natural demonstration that the developed methods are fit for their intended purpose and is not any more the inconsiderate checklist validation approach still generally performed to complete the filing required to obtain product marketing authorization. [less ▲]

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See detailCritical Review of Near-Infrared Spectroscopic Methods Validations in Pharmaceutical Applications
De Bleye, Charlotte ULg; Chavez, Pierre-François ULg; Mantanus, Jérôme ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2012), 69

Based on the large number of publications reported over the past five years, near-infrared spectroscopy (NIRS) is more and more considered an attractive and promising analytical tool regarding Process ... [more ▼]

Based on the large number of publications reported over the past five years, near-infrared spectroscopy (NIRS) is more and more considered an attractive and promising analytical tool regarding Process Analytical Technology and Green Chemistry. From the reviewed literature, few of these publications present a thoroughly validated NIRS method even if some guidelines have been published by different groups and regulatory authorities. However, as any analytical method, the validation of NIRS method is a mandatory step at the end of the development in order to give enough guarantees that each of the future results during routine use will be close enough to the true value. Besides the introduction of PAT concepts in the revised document of the European Pharmacopoeia (2.2.40) dealing with near-infrared spectroscopy recently published in Pharmeuropa, it agrees very well with this mandatory step. Indeed, the latter suggests to use similar analytical performance characteristics than those required for any analytical procedure based on acceptance criteria consistent with the intended use of the method. In this context, this review gives a comprehensive and critical overview of the methodologies applied to assess the validity of quantitative NIRS methods used in pharmaceutical applications. [less ▲]

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