References of "STP PHARMA PRATIQUES"
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See detailQuantitative analysis using near infrared spectroscopy, application to tablet content uniformity test, II
Ginot, Y.-M.; Bernard-Moulin, P.; Boiret, M. et al

in STP Pharma Pratiques (2014), 24(1), 3-36

The first part of this article [1] described the methodology to follow to develop a technique for the quantitative analysis of active substance in a solid tablet type formulation using near infrared ... [more ▼]

The first part of this article [1] described the methodology to follow to develop a technique for the quantitative analysis of active substance in a solid tablet type formulation using near infrared spectroscopy. It seems appropriate to complete this description by detailing the different steps involved through illustrated examples and by proposing useful guidelines for new users. The quantitative analysis example chosen is that of content uniformity (CU) of tablet type solid forms (cf. Ph. Eur. 2.9.6/2.9.40) [2], a test required in the pharmaceutical industry and for which this alternative quantitative analysis could offer substantial gains. It should be noted that the approach described applies to other types of quantitative analysis (mean assay, water content in raw materials, polymorph assay within a tablet, etc.). [less ▲]

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See detailUse of Raman spectrometry in the pharmaceutical field
Michelet, Alexandre; Boiret, Mathieu; Lemhachheche, Fatima et al

in STP Pharma Pratiques (2013), 23(2), 97-117

This document sets out the theoretical and practical fundamentals to guide users in the imple- mentation of Raman spectroscopy in industry or the university-hospital sector. It describes the principle of ... [more ▼]

This document sets out the theoretical and practical fundamentals to guide users in the imple- mentation of Raman spectroscopy in industry or the university-hospital sector. It describes the principle of this technique and currently available instruments. Since Raman spectrometers are used in a regulated context, the methodology of instru- ment qualification is discussed. Different types of applications encountered in the pharmaceutical field are presented: process monitoring, searching for and detecting counterfeits, and identifying raw materials on receipt. [less ▲]

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See detailQuantitative analysis using near infrared spectroscopy, Application to tablet content uniformity, I. Methodology
Ginot, Y. M.; Bernard-Moulin, P.; Cinier, R. et al

in STP PHARMA PRATIQUES (2010), 20(2), 117-135

This first document describes guidelines to develop a quantification method for active pharmaceutical ingredient content in solid dose formulation, using near-infrared spectroscopy. This new approach ... [more ▼]

This first document describes guidelines to develop a quantification method for active pharmaceutical ingredient content in solid dose formulation, using near-infrared spectroscopy. This new approach offers several advantages over classical techniques, in particular for tablets content uniformity determination. This document is intended to help users addressing the numerous questions pertaining to number and types of samples, usable spectral range for quantification, importance of the reference method, development of a model and potential pitfalls, use of chemometrics tools and method validation. It also offers a statistical support that used as an aid for decision for routine controls, when a sample falls near acceptance limits. The document gathers basic principles and will be complemented by a second article with practical examples to illustrate the methodology. [less ▲]

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See detailValidation des procédures analytiques quantitatives :harmonisation des démarches - Partie III. Exemples d’application
Hubert, Philippe ULg; Nguyen-Huu, Jean-Jacques; Boulanger, Bruno ULg et al

in STP PHARMA PRATIQUES (2006), 16(2), 87-121

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This third and last document aims ... [more ▼]

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This third and last document aims at illustrating this methodology and the statistics used. Therefore the validation of real case methods are proposed such as methods for the quality control of drugs, for the quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments. Furthermore, different types of analytical methods are used in order to demonstrate the applicability of the proposed approach to a wide range of methods such as liquid chromatography (LC-UV, LC-MS), spectrophotometry or ELISA. [less ▲]

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See detailValidation des procédures analytiques quantitatives :Partie II - Statistiques
Hubert, Philippe ULg; Nguyen-Huu, Jean-Jacques; Boulanger, Bruno ULg et al

in STP PHARMA PRATIQUES (2006), 16(1), 28-58

In a first document, a SFSTP Commission on the Validation of Analytical Procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the ... [more ▼]

In a first document, a SFSTP Commission on the Validation of Analytical Procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this second part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described. This tool, based on the concept of total error (bias + standard deviation), allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. [less ▲]

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See detailValidation des procédures analytiques quantitatives, Harmonisation des démarches
Hubert, Philippe ULg; Nguyen-Huu, J. J.; Boulanger, Bruno ULg et al

in STP Pharma Pratiques (2003), 13(3), 101-138

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See detailExample of application of the new strategy proposed for the validation of chromatographic bioanalytical methods
Chapuzet, E.; Mercier, N.; Bervoas-Martin, S. et al

in STP Pharma Pratiques (2000), 10(2), 79-101

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See detailNew strategy for the validation of chromatographic bioanalytical methods
Chapuzet, E.; Mercier, N.; Bervoas-Martin, S. et al

in STP Pharma Pratiques (2000), 10(1), 21-38

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See detailMéthodes chromatographiques de dosage dans les milieux biologiques : exemple d'application de la stratégie de validation - Rapport d'une commission SFSTP
Chapuzet, E.; Mercier, N.; Bervoas-Martin, S. et al

in STP Pharma Pratiques (1998), 8(2), 81-107

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See detailMéthodes chromatographiques de dosage dans les milieux biologiques : stratégie de validation - Rapport d'une commission SFSTP
Chapuzet, E.; Mercier, N.; Bervoas-Martin, S. et al

in STP Pharma Pratiques (1997), 7(3), 169-194

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See detailFormes pharmaceutiques à libération prolongée en médecine vétérinaire : systèmes à rétention dans le réticulo-rumen = Sustained-released veterinary dosage forms : retention devices in the reticulorumen
Evrard, Brigitte ULg; Delattre, Luc ULg

in STP Pharma Pratiques (1996), 6(6), 479-486

L'industrialisation des productions animales a mis en évidence la nécessité d'éviter des administrations réitérées chez des animaux dont la manipulation est difficile, et de développer des formes à ... [more ▼]

L'industrialisation des productions animales a mis en évidence la nécessité d'éviter des administrations réitérées chez des animaux dont la manipulation est difficile, et de développer des formes à libération contrôlée ou du moins fortement prolongée. L'anatomie particulière du tube digestive des ruminants offre en outre des possibilités inédites pour le développement de tels systèmes thérapeutiques, notamment grâce à la rétention dans le réticulo-rumen. De telles formes ont essentiellement été développées pour l'administration de médicaments antiparasitaires et antibactériens, de suppléments nutritionnels et de promoteurs croissance. Cette revue décrit les applications potentielles de la technologie des formes à libération contrôlée et prolongée en médecine vétérinaire et les différents dispositifs à rétention dans le réticulo-rumen décrits dans la littérature, brevetés ou commercialisés. More intensive methods ofanimal husbandry have revealed the necessity of avoiding repeated administration ofmedication to animals which are difficult to handle and of developing controlled and sustained release dosage forms. The physiological characteristics of the digestive tract of ruminants provide unique opportunity for controlled release technology, especially due to the animal's reticulo-rumen retention ability. The majorareas of application of these controlled and sustained release dosage forms include the delivery of antibiotic and antiparasitic agents, trace nutrients and growth promoting agents. This review describes the potential applications of controlled and sustained release technology in veterinary medicine and the various reticulo-rumen retention devices which are patented, marketed or described in the literature. [less ▲]

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