Juan Padierna-Olivos, Juan Francisco Sánchez-Ruiz, Gustavo Alonso Martínez-Blanco, Carlos Arturo Medina-García, Brenda Magali Lin-Li Lagunas-Bucio, Ariadna Rosas-Hernández, Cecilia Padierna-Mota, Alberto Padierna-Mota, Carlos Gershenson-García
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引用次数: 0
Abstract
Purpose
The purpose of this work is to show the results of automating with AI, the interpretation of human albumin and immunoglobulin identity tests in commercial drugs for intravenous application, and to evaluate its incorporation into routine laboratory analytical activities, in compliance with Mexican health regulations.
Research Question
Is it possible to apply AI to determine the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application, as a support for issuing analytical certificates, in compliance with Mexican health regulations?
Methods
In this work we developed an AI method that supports the determination of the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application.
The identity of human albumin and immunoglobulin was determined using the validated pharmacopeial method of immunoelectrophoresis on agarose plates. The agarose plates were photographed using a webcam. The photographs were processed by a pre-trained AI algorithm. The data obtained by the AI were compared with the results from the agarose plates.
Results
The selectivity, sensitivity, specificity and predictive value were determined, as well as the performance evaluation with respect to the results obtained on the agarose plates. In all cases, the parameters evaluated were satisfactory > 95%. The analysts who performed the analytical execution considered it satisfactory to incorporate AI into the identity tests of human immunoglobulin and albumin in commercial drugs for intravenous application.
Conclusions
The AI method for identifying human immunoglobulin and human albumin in commercial intravenous medications is reliable and will be perfected for submission to Mexican regulatory authorities.
期刊介绍：
The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories:
Materials science,
Product design,
Process design, optimization, automation and control,
Facilities; Information management,
Regulatory policy and strategy,
Supply chain developments ,
Education and professional development,
Journal of Pharmaceutical Innovation publishes four issues a year.
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