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Advisor(s)
Abstract(s)
Os radiofármacos são medicamentos que contém átomos radioativos utilizados para fins de diagnóstico, monitorização e tratamento de algumas patologias, sendo administrados na sua maioria por via intravenosa. A radiofarmácia ocupa-se da pesquisa e desenvolvimento, produção, controlo de qualidade, garantia da qualidade e outros aspetos relacionados com os radiofármacos, sendo um ramo inovador e desafiante na área da Farmácia. O controlo de qualidade na indústria farmacêutica é um conjunto de procedimentos destinados a verificar a qualidade de vários intervenientes no circuito do medicamento (desde matériasprimas ao produto acabado), de forma a que a seja garantida a obtenção de medicamentos seguros, eficazes e de qualidade.
Pretende-se com o presente trabalho final de mestrado, na sequência do estágio de natureza profissional com duração de 6 meses desenvolvido no Instituto de Ciências Nucleares Aplicadas à Saúde (ICNAS), descrever o estado da arte, atividades desenvolvidas e competências adquiridas no contexto do controlo de qualidade de radiofármacos na indústria farmacêutica. É ainda apresentado um estudo de caso referente ao radiofármaco 11C-Acetato, para o qual foi validado, de acordo com as guidelines aplicáveis, o método proposto de análise de solventes residuais (éter dietílico e tetrahidrofurano) por cromatografia gasosa, com apresentação dos resultados especificidade, exatidão, precisão, linearidade, alcance, limite de deteção, limite de quantificação e robustez.
ABSTRACT - Radiopharmaceuticals are medicines that contain radioactive atoms used for diagnostic purposes, monitoring, and the treatment of some pathologies, being administrated mostly intravenously. Radiopharmacy takes care of the research and development, production, quality control, quality warranty, and other aspects related to radiopharmaceuticals, being an innovative and challenging branch in the area of pharmacy. Quality control in the pharmaceutical industry is a set of procedures destined to check the quality of various stakeholders in the medicine circuit (from raw material to the finished product), in a way that it is guaranteed that safe, effective, and quality medicines are obtained. With this final master paper it is intended, in the sequence of the professional internship lasting 6 months developed in the Institution of Nuclear Sciences Applied to Health (ICNAS), the description of the state of art, activities developed and acquired skills in the context of radiopharmaceuticals quality control in the pharmaceutical industry. It is also presented a study of the case-referent to the 11C-Acetate radiopharmaceutical, for which it was authenticated, according to the guidelines applied, the proposed method of residual solvent analysis (diethyl ether and tetrahydrofuran) by gas chromatography, with the presented results of specificity, accuracy, precision, linearity, range, detection limit, quantification limit and robustness.
ABSTRACT - Radiopharmaceuticals are medicines that contain radioactive atoms used for diagnostic purposes, monitoring, and the treatment of some pathologies, being administrated mostly intravenously. Radiopharmacy takes care of the research and development, production, quality control, quality warranty, and other aspects related to radiopharmaceuticals, being an innovative and challenging branch in the area of pharmacy. Quality control in the pharmaceutical industry is a set of procedures destined to check the quality of various stakeholders in the medicine circuit (from raw material to the finished product), in a way that it is guaranteed that safe, effective, and quality medicines are obtained. With this final master paper it is intended, in the sequence of the professional internship lasting 6 months developed in the Institution of Nuclear Sciences Applied to Health (ICNAS), the description of the state of art, activities developed and acquired skills in the context of radiopharmaceuticals quality control in the pharmaceutical industry. It is also presented a study of the case-referent to the 11C-Acetate radiopharmaceutical, for which it was authenticated, according to the guidelines applied, the proposed method of residual solvent analysis (diethyl ether and tetrahydrofuran) by gas chromatography, with the presented results of specificity, accuracy, precision, linearity, range, detection limit, quantification limit and robustness.
Description
Mestrado em Farmácia. - Área de especialização: Farmacologia e Farmacoterapia Avançada
Keywords
Farmácia Indústria farmacêutica Controlo de qualidade Radiofármaco 11C acetato Validação de método analítico Pharmacy Pharmaceutical industry Quality control Radiopharmaceutical 11C acetate Analytical method validation
Citation
Simões CB. Estágio em indústria farmacêutica [dissertation]. Lisboa: Escola Superior de Tecnologia da Saúde de Lisboa/Instituto Politécnico de Lisboa; 2021.
Publisher
Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa