Pharmacist and PhD in toxicology and toxicological analysis from the University of São Paulo (FCF-USP, 2014). Experience in developing analytical methods and toxicological assessment of impurities in medicines and active pharmaceutical ingredients (degradation products, mutagenic impurities, elemental, extractable and leachable impurities) through in silico tools and integrated risk assessment. She worked in the pharmaceutical industry (Aché Laboratórios) actively participating in the scientific and regulatory development of these areas. She is currently a member of the board of directors of SBTox (Brazilian Society of Toxicology), member of the toxicology working group of the Federal Pharmacy Council (GTTox- CFF), member of IFDC (International Forced Degradation Community), member of the Brazilian pharmacopoeia collegiate and consultant at Spektra Consultoria working mainly in the areas of toxicological assessment of impurities in compliance with ANVISA and ICH regulations (RDC 53/2015, RDC 677/2022, ICH M7, ICH Q3C, D and E among others) and determination of HBEL (Health-Based Exposure Limit) to control cross-contamination in compliance with RDC 658/2022 on good drug manufacturing practices. (Source: Lattes Curriculum)
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Biological medical products (biopharmaceutical, biotherapeutics or biologics) are an innovate family of therapeutic drugs that have revolutionized the treatment of many serious disease such as cancer, autoimmune disorders or diabetes. Biologics are complex macromolecules that are produced from genetically modified living organisms, hence expensive to produce and purchase. Consequently, an…
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