Debora Bressanim de Aquino Calemi

Holds a Bachelor's degree in Pharmacy from Faculdades Oswaldo Cruz (2014) and a Masters degree in Pharmacology from the University of Campinas (UNICAMP). During undergraduate studies (20122014), completed an internship at the São Paulo Institute of Criminalistics, working on the analysis of illicit drugs seized by law enforcement agencies using the following techniques: thin-layer chromatography (TLC), colorimetric tests, gas chromatography coupled with mass spectrometry (GC-MS), gas chromatography with flame ionization detection (GC-FID), high-performance liquid chromatography (HPLC), capillary electrophoresis with diode array detection (CE-DAD), and immunoassay tests.Was awarded a Scientific Initiation Scholarship (FAPESP, grant n 2012/22071-4), under the supervision of Professor Dr. Marina Franco Maggi Tavares (IQ-USP), with the project titled: "Use of Capillary Electrophoresis with Diode Array Detection (CE-DAD) to Investigate the Enantiomeric Purity of Methamphetamine Used as a Drug of Abuse." During this period, performed qualitative and quantitative analysis of tablets seized between 2011 and 2013 using GC-MS, determined enantiomeric purity and quantified isomers using CE-DAD, and characterized methamphetamine synthesis residues to identify the synthetic route using GC-MS and GC-FID.Currently works in the pharmaceutical industry, with a focus on the coordination, planning, and technical review of pharmacokinetic studies (relative bioavailability, bioequivalence, pharmacokinetic interaction, food effect, and linearity), aimed at demonstrating the safety and efficacy of generic, similar, innovative, and post-marketing phase drugs.Responsible for preparing rationales and technical reports for biowaiver studies in accordance with RDC No. 749/2022 and its updates, contributing to the optimization of regulatory submissions and strategies. Also has experience in the development and validation of analytical methods in accordance with RDC No. 941/2024 and Guide No. 72, dated April 1, 2024 (ANVISA), including the execution of the analytical phase of relative bioavailability and bioequivalence studies. (Source: Lattes Curriculum)