Jérôme Mantanus

TL;DR: A predictive risk-based approach was set up in order to account for the uncertainties and correlations found in the process and in the derived critical quality attributes such as the yield, the moisture content, the inhalable fraction of powder, the compressibility index, and the Hausner ratio.

TL;DR: This review gives a comprehensive and critical overview of the methodologies applied to assess the validity of quantitative NIRS methods used in pharmaceutical applications.

TL;DR: The present study confirmed that NIR spectroscopy could be used in the PAT concept as a non-invasive, non-destructive and fast technique for moisture content determination in pharmaceutical pellets.

TL;DR: A robust near infrared (NIR) calibration model able to determine the acetaminophen content of a low-dose syrup formulation (2%, w/v) was developed and a good agreement was found between the NIR method and the theoretical concentrations.

TL;DR: 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, and 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.