  Vibrational spectroscopy in pharmaceutical industry: From development of the most appropriate predictive model to routine implementationZiemons, Eric  ; Mantanus, Jérôme ; Rozet, Eric et alPoster (2010, December 08) Detailed reference viewed: 69 (7 ULg)Use of tolerance intervals in the development of near infrared spectroscopic methods: An innovative way to select the most appropriate calibration modelZiemons, Eric ; Mantanus, Jérôme ; Rozet, Eric et alPoster (2010, December 02) Detailed reference viewed: 57 (8 ULg) NIR monitoring of solid and liquid forms manufacturing – Development and validation of in-line quantitative methodsMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2010, November 15) Detailed reference viewed: 126 (40 ULg)An innovative approach to select the prediction model in the development of NIR spectroscopy methodsZiemons, Eric ; Mantanus, Jérôme ; Rozet, Eric et alPoster (2010, September) Detailed reference viewed: 134 (37 ULg)NIR as a PAT tool for solid and liquid forms manufacturing - Development and validation of in-line quantitative methodsMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2010, May 05) Detailed reference viewed: 91 (22 ULg) Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: Method development, validation and reliability evaluationMantanus, Jérôme ; Ziemons, Eric ; Lebrun, Pierre et alin Talanta (2010), 80 A robust near infrared (NIR) method able to quantify the active content of pilot non-coated pharmaceutical pellets was developed. A protocol of calibration was followed, involving 2 operators, independent ... [more ▼] A robust near infrared (NIR) method able to quantify the active content of pilot non-coated pharmaceutical pellets was developed. A protocol of calibration was followed, involving 2 operators, independent pilot batches of non-coated pharmaceutical pellets and two different NIR acquisition temperatures. Prediction models based on Partial Least Squares (PLS) regression were then carried out. Afterwards, the NIR method was fully validated for an active content ranging from 80 to 120% of the usual active content using new independent pilot batches to evaluate the adequacy of the method to its final purpose. Conventional criteria such as the R2, the Root Mean Square Error of Calibration (RMSEC), the Root Mean Square Error of Prediction (RMSEP) and the number of PLS factors enabled the selection of models with good predictive potential. However, such criteria sometimes fail to choose the most fitted for purpose model. Therefore, a novel approach based on accuracy profiles of the validation results was used, providing a visual representation of the actual and future performances of the models. Following this approach, the prediction model using signal pre-treatment Multiplicative Scatter Correction (MSC) was chosen as it showed the best ability to quantify accurately the active content over the 80–120% active content range. The reliability of the NIR method was tested with new pilot batches of non-coated pharmaceutical pellets containing 90 and 110% of the usual active content, with blends of validation batches and industrial batches. All those batches were also analyzed by the HPLC reference method and relative errors were calculated: the results showed low relative errors in full accordance with the results obtained during the validation of the method, indicating the reliability of the NIR method and its interchangeability with the HPLC reference method. [less ▲] Detailed reference viewed: 156 (39 ULg)Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) methodMantanus, Jérôme ; Ziemons, Eric ; Rozet, Eric et alin Talanta (2010), 83 The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non ... [more ▼] The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non-invasively interface a dispersive NIR spectrometer with four realistic particle streams existing in the pellets manufacturing environment. Regardless of the particle stream characteristics investigated, NIR together with principal component analysis (PCA) was able to classify the samples according to their active content. Further, one of these particle stream interfaces was non-invasively investigated with a FT-NIR spectrometer. A predictive model based on Partial Least Squares (PLS) regression was able to determine the active content of pharmaceutical pellets. The NIR method was finally validated with an external validation set for an API concentration range from 80 to 120 % of the targeted active content. The prediction error of 0.9 % (root mean standard error of prediction, RMSEP) was low, indicating the accuracy of the NIR method. The accuracy profile on the validation results, an innovative approach based on tolerance intervals, demonstrated the actual and future performance of the in-line NIR method. Accordingly, the present approach paves the way for real-time release-based quality system. [less ▲] Detailed reference viewed: 144 (49 ULg)Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: Method development, validation and reliability evaluationMantanus, Jérôme ; Ziemons, Eric ; Lebrun, Pierre et alPoster (2009, November) Detailed reference viewed: 60 (15 ULg)Validation of a near infrared spectroscopy method for the quantitative determination of an active ingredient in non-coated pharmaceutical pelletsMantanus, Jérôme ; Ziemons, Eric ; Lebrun, Pierre et alPoster (2009, September) Detailed reference viewed: 63 (13 ULg)Production line real time near infrared (NIR) monitoringMantanus, Jérôme ; Ziemons, Eric ; et alConference (2009, September) Detailed reference viewed: 51 (13 ULg)Quantitative in-line monitoring of pharmaceutical pellets active content using near infrared spectroscopyMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2009, August) Detailed reference viewed: 50 (12 ULg)Interfacing near infrared (NIR) spectroscopy with production line - Role of sample movement and densityMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2009, June) Detailed reference viewed: 43 (9 ULg)Determination of moisture content in pharmaceutical pellets using near infrared spectroscopy: Method development and validationMantanus, Jérôme ; Ziemons, Eric ; Lebrun, Pierre et alConference (2008) Detailed reference viewed: 24 (3 ULg)Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: model selection, evaluation and validationMantanus, Jérôme ; Ziemons, Eric ; Lebrun, Pierre et alPoster (2008) Detailed reference viewed: 130 (26 ULg) |
||
