Background: Analytical validation is a sequence of operations aiming to evaluate the accuracy, reliability, and cost of analytical results for making informed decisions in method selection and meeting the requirements of regulatory institutions. Objective: This study aims to perform an analytical validation by comparing three different approaches: the accuracy profile, the uncertainty profile, and the conventional validation to assess the capability of each method in confirming the robustness of the results. Methods: The accuracy profile offers a comprehensive assessment of analytical performance and integrates systematic and random errors to determine if future results will satisfy the predefined acceptance limits. Meanwhile, the uncertainty profile, which is complementary and innovative, allows uncertainty estimation from validation data. These approaches were developed after conventional validation that relies on statistical methodologies based on separate evaluations of method criteria to provide a comparative framework for evaluating new methods. Results: This comparison will give recommendations for best practices related to analytical validation. The uncertainty profile is a graphical decision-making tool for determining full validation by integrating analytical validation and the estimation of measurement uncertainty, evaluating two statistical methods: β-expectation tolerance intervals and β-content, γ-confidence tolerance intervals, using a formula introduced by Saffaj and Ihssane, predicting that 95% of future results will fall within the acceptance limits of ±5%, revealing that the tolerance intervals for β-expectation are smaller than β-content, γ-confidence. Conclusion: The total error approaches offer robust recommendations for optimal methods for routine application. Highlights: This study highlights the critical need for appropriate analytical validation and the challenges arising from the absence of clear guidelines for that purpose. Different approaches emphasize the significant impact of the choice of an adequate method, which remains pivotal for providing accurate results in real-world scenarios. Concrete examples and simulations illustrate the viewpoints associated with different approaches to making decisions.

Background: Azithromycin is a complex molecule derived from erythromycin. The control of its dosage in conventional release tablets requires the analytical validation of its method to ensure accurate quantification and provide confidence in the reliability of the results for informed decision-making. Objective: This study aims to validate an innovative method for azithromycin quantification using the accuracy profile. Additionally, a comparison is made between the uncertainty measurements calculated from the validation data using two formulas proposed by Feinberg et al. and Saffaj and Ihssane and contrasted with the ISO GUM approach. Methods: A liquid chromatography system intended for azithromycin analysis equipped with a reversed-phase C18 stationary phase consisting of octadecyl silyl vinyl polymer in a UV detector operating at 210 nm at a temperature of 40°C in isocratic elution using a mobile phase of acetonitrile and dipotassium hydrogen phosphate buffer (6.7 g/L), in the fraction of (60:40, v/v) at pH = 8. Results: The various accuracy profiles are illustrated to ensure that a known quantity of anticipated findings acquired through the method stand inside the tolerance interval of 95% and remain within the previously set acceptance limits of ±5%. Measurement uncertainty provides comparable values using both formulas of the total error approach. However, it was observed that the ISO-GUM approach tends to overestimate the expanded uncertainty. Specifically, while the ISO-GUM approach provides a rigorous framework, the use of the validation data offers a more empirical uncertainty estimation. Conclusion: The approach based on the total error grants the ability to accurately close the routine uncertainty, emphasizing a complete validation. Highlights: The proposed method is robust for pharmaceutical application, demonstrating good accuracy, with 95% of tolerance and uncertainty limits falling within the predefined acceptance limits of ±5%.

Objective: The aim of this study was to assess the satisfaction of pharmacy students with e-learning during the COVID-19 lockdown.    Methods: A cross-sectional study was conducted in the Pharmacy School of Mohammed VI University of Health Sciences of Casablanca in April 2020. An anonymous questionnaire previously validated by the pedagogical committee of the university was administered to students via google forms. Results: A total of 154 responses were received, 122 (79.22%) were female students. The majority of students were satisfied with the general organisation (between 60.4% and 81.8% depending on the studied parameter), e-learning (63.6%), educational content (between 61% and 85.7% depending on the studied parameter), self-assessment methods (between 64.9% and 84.4% depending on the studied parameter), adaptation (63%), the involvement of teachers (83.8%), and the administration of the faculty (75.9%). Multivariate analysis showed that two factors were significantly associated with student satisfaction related to e-learning in this study. This corresponds to the level of study (p-value = 0.026; OR=4.009; IC_95% [1.176-13.663]) and the adaptation (p-value = 0.004; OR=3.671; IC_95% [1.519-8.868]). This study found that satisfaction levels were higher among third year students, which could be interpreted by the fact that they were more familiar with e-learning.    Conclusion: Students were mostly satisfied with e-learning during the lockdown. The experience from this study showed an advantage for other schools by the partial introduction of e-learning training as a teaching method in normal situations in order to better deal with emergency situations.