Introduction: The intergovernmental organizations Organisation for Economic Co-operation and Development (OECD) and Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) have developed guidelines for the use of in vitro models for toxicological evaluation of chemicals. However, the presence of manual steps and the requirement of multiple tools for data analysis, apart from being costly and time-consuming, can inadvertently introduce errors by researchers. Objectives: We have developed the SAEDC platform (Technological Solution for Exploratory Data Analysis and Statistics for Cytotoxicity, in Portuguese), which enables analysis of cytotoxicity data from assays following OECD Guideline No. 129. Methodology: In vitro experimental data were used to compare with the analysis methodology suggested in the Guideline. We analyzed 117 data sets covering chemicals from Category I to Unclassified according to GHS classification. Results: The four-parameters of non-linear regression (4PL) calculated by the SAEDC platform showed no significant differences compared to standard methodology in any of the data sets (p > 0.05). The coefficient of determination (Rsquared) also demonstrated not only a good fit of the 4PL model to the data but also significant similarity to values obtained by the conventional methodology. Finally, the SAEDC platform predicted LD50 values for the chemicals from IC50, using the Registry of Cytotoxicity (RC) regression models. Conclusion: The comparison with the standard data analysis methodology revealed that SAEDC platform fulfills the requirements for cytotoxicity data analysis, generating reliable and accurate results with fewer steps performed by researchers. The use of SAEDC platform for obtaining toxicity values can reduce analysis time compared to the standard methodology proposed by regulatory agencies. Thus, automation of the analysis using the SAEDC platform has the potential to save time and resources for cytotoxicity researchers and laboratories while generating reliable results.

Bernardo Zoehler; Alessandra Melo de Aguiar; Guilherme Ferreira Silveira. SAEDC: Development of a technological solution for exploratory data analysis and statistics in cytotoxicity. Computational and Structural Biotechnology Journal 2024, 23, 483 -490.

Bernardo Zoehler, Alessandra Melo de Aguiar, Guilherme Ferreira Silveira. SAEDC: Development of a technological solution for exploratory data analysis and statistics in cytotoxicity. Computational and Structural Biotechnology Journal. 2024; 23 ():483-490.

Bernardo Zoehler; Alessandra Melo de Aguiar; Guilherme Ferreira Silveira. 2024. "SAEDC: Development of a technological solution for exploratory data analysis and statistics in cytotoxicity." Computational and Structural Biotechnology Journal 23, no. : 483-490.

Pharmaceutical companies are seen as slow in adopting principles of operation excellence and advanced technologies. This article aims to explore the reasons why an industry, recognized as profitable and intensive in capital and science, is reluctant to implement emerging technologies and management tools capable of improving its operational performance. Operational excellence incorporates the fundamentals of Lean Six Sigma (LSS) methodology to the organizational culture and strategic management of companies. LSS is also known as the most used approach in continuous improvement programs in the industrial segment. Despite being a methodology used for many years, LSS continues to evolve, incorporating new trends such as data science technologies, which significantly maximize LSS results. Applying LSS integrated with I4.0 can generate essential information for the organization's decision makers through data identification, extraction, and analysis. In this sense, information technology is a strong ally of operational performance management in the pharmaceutical industry.

Beatriz Maria Simões Ramos da Silva; Vicente Aguilar Nepomuceno de Oliveira; Jorge Magalhães; Ghmt. Pharmaceutical Manufacturing and Health Information Technology. 2024, 1 -21.

Beatriz Maria Simões Ramos da Silva, Vicente Aguilar Nepomuceno de Oliveira, Jorge Magalhães, Ghmt. Pharmaceutical Manufacturing and Health Information Technology. . 2024; ():1-21.

Beatriz Maria Simões Ramos da Silva; Vicente Aguilar Nepomuceno de Oliveira; Jorge Magalhães; Ghmt. 2024. "Pharmaceutical Manufacturing and Health Information Technology." , no. : 1-21.

José Noé da Silva Júnior; Kamila Kassia dos Santos Oliveira; Ana Carla da Silva; Virginia Maria Barros de Lorena; Daniela de Araújo Viana Marques; Raquel Pedrosa Bezerra; Ana Lúcia Figueiredo Porto. Microalgae extracts modulates the immune response in Trypanosoma cruzi-infected human cells. Cytokine 2024, 179, 156621 .

José Noé da Silva Júnior, Kamila Kassia dos Santos Oliveira, Ana Carla da Silva, Virginia Maria Barros de Lorena, Daniela de Araújo Viana Marques, Raquel Pedrosa Bezerra, Ana Lúcia Figueiredo Porto. Microalgae extracts modulates the immune response in Trypanosoma cruzi-infected human cells. Cytokine. 2024; 179 ():156621.

José Noé da Silva Júnior; Kamila Kassia dos Santos Oliveira; Ana Carla da Silva; Virginia Maria Barros de Lorena; Daniela de Araújo Viana Marques; Raquel Pedrosa Bezerra; Ana Lúcia Figueiredo Porto. 2024. "Microalgae extracts modulates the immune response in Trypanosoma cruzi-infected human cells." Cytokine 179, no. : 156621.