Forced degradation, analytical methods, qualification, and new guidance from ANVISA
The requirements by ANVISA for conducting forced degradation studies and developing a stability-indicating analytical method are described in RDC 58 (recently revised to RDC 53/15), and the guidelines for meeting these requirements are published in the revised CP68. The intent is to use forced degradation to discover and identify the “potential” degradation profile under a […]
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 […]
Altox researchers present alternatives to animal use at the Second Pan-American Conference for Alternative Methods in 2018
Between August 23 and 24, 2018, the Second Pan-American Conference for Alternative Methods was held in Rio de Janeiro and was attended by Altox researchers with presentations and scientific papers. Started in 2016 in Baltimore and with the next conference scheduled to be based in Canada, the second meeting was attended by some of the […]
An artificial intelligence platform developed by the Brazilian company Altox will avoid using animals in tests
A computational model platform of artificial intelligence for the toxicological and environmental evaluation of molecules has been developed since 2017 by the company Altox in São Paulo as part of the Innovative Research Project in Small Companies (from Portuguese PIPE), winner of one of the FAPESP awards. In 2019, Altox started a partnership with companies […]
Artificial intelligence (AI) as a competitive differential in toxicological evaluation and rationalization of animal use
The impact of artificial intelligence (AI) on various economic sectors is a well-known fact and the changes in perspectives in different markets in this context have been very rapid, opening new fields of opportunities and applications. The Organization for Economic Co-operation and Development (OECD) estimated in 2016 that AI already supported more than 50% of […]
Safety assessment of extractables and leachables: Analytical aspects in line with toxicological aspects
With advances in analytical techniques and their application in the context of drugs, undesirable substances from different origins in decreasing concentrations are the objects of study and specific standards, involving (i) the development of analytical methods and (ii) the evaluation of security and the justification of limits: In addition to impurities related to the manufacturing […]
