Altox director presents a seminar on the safety of degradation products and impurities at ANVISA headquarters

On February 5, 2019, Altox director prof. MSc. Carlos Eduardo Matos presented the seminar "RDC53/2015 and ICH M7: Safety assessment of degradation products and impurities with in silico models" (program content presented below) at ANVISA headquarters in Brasilia.

The purpose of the event was to share experiences in the context of the safety assessment of degradation products and impurities, especially discussions about good practices in the design process of qualification studies and the application of in silico models. Approximately 50 ANVISA specialists were present. The event was part of a set of Altox initiatives intended for the dissemination of knowledge and technologies developed as part of the iS-Tox project financed by FAPESP, with the perspective of a return to society.

Altox has developed the first in silico models platform for regulatory purposes in Latin America in an innovative small business research (PIPE) project funded by FAPESP, and this technology represents not only a scientific breakthrough in Brazil, but a highly positive impact in the context of the safety assessment of molecules in the country, enabling compliance with the new guidelines that recommend the use of in silico models in the processes of the safety evaluation and toxicity tests for companies in the pharmaceutical, cosmetic, agrochemical, and veterinary sectors.

One of the modules in the iS-Tox® platform (In Silico Toxicology Platform) developed by the Altox team is Genotox-iS, composed of artificial intelligence and alert verification models that perform toxicity evaluations of impurities according to ICH criteria M7, one of the topics foreseen in the Common Technical Document (CTD) and Manual CTD-3.2.S, recently published by the National Agency of Sanitary Surveillance for the registration of active pharmaceutical ingredients (APIs).

For the technical director of Altox, in addition to the exchange of experiences, the event enabled the presentation of technical-scientific advances in the field, as well as discussing consensuses and good practices that positively contribute to the process of safety evaluating products in Brazil.

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