Desenvolvimento farmacêutico de um medicamento: área analítica
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Data
2014
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A formação académica que adquiri em engenharia biotecnológica permitiu-me alcançar conhecimentos, desenvolver capacidades e competências, em diversas áreas científicas que foram potenciadas com a minha experiência profissional.
No presente Relatório Profissional será demonstrada a experiência profissional e formação contínua que obtive na área da indústria farmacêutica ao longo destes nove anos de vida profissional.
De forma a demonstrar os conhecimentos, capacidades e competências adquiridas com a função que desempenho integrada numa equipa de Desenvolvimento Farmacêutico, serão abordadas as tarefas que realizo nas várias etapas de desenvolvimento de um novo produto farmacêutico.
Vai ser relatado o processo efetuado para o desenvolvimento de um medicamento genérico sob a forma farmacêutica de cápsulas com elevada qualidade, de forma a garantir o seu desempenho ao nível da segurança e eficácia terapêutica.
Durante o processo de desenvolvimento farmacêutico do medicamento genérico participei na área analítica, nas seguintes etapas: caracterização físico-química da substância ativa, desenvolvimento galénico, desenvolvimento e validação dos métodos analíticos e estudos de estabilidade.
As principais metodologias e ensaios que apliquei no cumprimento das várias etapas do processo de desenvolvimento do medicamento, bem como o tipo de ferramentas que utilizei e os resultados que obtive foram descritos neste relatório.
The educational background acquired in biotechnological engineering allowed me to achieve knowledge, develop skills and competencies in various scientific fields that have been enhanced with my professional experience. The present Professional Report will demonstrate the work experience and continuing training that I got in the pharmaceutical industry area over these nine years of professional life. In order to demonstrate the knowledge, skills and competencies acquired through the role that I perform integrated in a Pharmaceutical Development team, will be discuss the tasks that I carry out in the various stages of a new pharmaceutical product development. Will be reported the process performed for a generic drug development in the pharmaceutical form of capsules with high quality, to ensure its performance in terms of therapeutic efficacy and safety. During the generic drug pharmaceutical development I participated in the analytical area, in the following steps: physico-chemical characterization of the active substance, galenic development, development and validation of analytical methods and stability studies. The main methods and tests that I applied to comply the various drug process development stages as well as the kind of tools that I used and the achieved results were described in this report.
The educational background acquired in biotechnological engineering allowed me to achieve knowledge, develop skills and competencies in various scientific fields that have been enhanced with my professional experience. The present Professional Report will demonstrate the work experience and continuing training that I got in the pharmaceutical industry area over these nine years of professional life. In order to demonstrate the knowledge, skills and competencies acquired through the role that I perform integrated in a Pharmaceutical Development team, will be discuss the tasks that I carry out in the various stages of a new pharmaceutical product development. Will be reported the process performed for a generic drug development in the pharmaceutical form of capsules with high quality, to ensure its performance in terms of therapeutic efficacy and safety. During the generic drug pharmaceutical development I participated in the analytical area, in the following steps: physico-chemical characterization of the active substance, galenic development, development and validation of analytical methods and stability studies. The main methods and tests that I applied to comply the various drug process development stages as well as the kind of tools that I used and the achieved results were described in this report.
Descrição
Orientação: Maria Nubélia Silvestre Bravo ; co-orientação: Tiago Costa Cabral Figueiredo
Palavras-chave
ENGENHARIA BIOTECNOLÓGICA, MESTRADO EM ENGENHARIA BIOTECNOLÓGICA, TECNOLOGIA FARMACÊUTICA, MEDICAMENTOS, INDÚSTRIA FARMACÊUTICA, MEDICAMENTOS GENÉRICOS, METODOLOGIAS, BIOTECHNOLOGY ENGINEERING, PHARMACEUTICAL TECHNOLOGY, DRUGS, PHARMACEUTICAL INDUSTRY, GENERIC DRUGS, METHODOLOGIES