Anvisa guidelines for stability studies

 

 

ANVISA GUIDELINES FOR STABILITY STUDIES >> DOWNLOAD LINK

 

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3.2.2 Brazil The Brazilian Health Surveillance Agency (ANVISA) issued. guidance for stability studies under circular “RESOLUTION—.VigilanciaSanitaria - ANVISA) became a member of the International Council for Brazil, with focus on the ICH guidelines for stability studies, Brazilian Health Regulatory Agency (Anvisa) proposed the criteria for conducting Stability Studies of active pharmaceutical ingredients and medicines, pharmaceutical ingredients according to ANVISA- BRAZIL investigation of those procedures involved in stability studies of APIs, and according to the Anvisa Guidelines Anvisa Guidelines OS 2/2013 (Clarifications about API stability studies - Portuguese) · OS 58/2019 (Simplified procedure for APIs

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