Aspectos gerais de QBD – Quality by Design – em indústrias farmacêuticas nacionais
Data
2020
Autores
Sugimoto, Yvan Pelicer 
Orientadores
Minarini, Paulo Roberto Regazi
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O estudo de Quality by Design (QbD) abrange um modelo sistemático de
desenvolvimento farmacêutico e possui como fundamento estudos e conhecimentos técnicocientíficos alinhados com o gerenciamento de riscos e são associados ao produto e ao
processo farmacêutico. Este estudo é conceituado e aplicado em diversos lugares no mundo
e leva diversos benefícios para as indústrias farmacêuticas para lançamentos de novos
medicamentos e manutenção de produtos já comercializados. Nas indústrias nacionais este
conceito está sendo cada vez mais discutido uma vez que apresenta certas vantagens em
relação ao desenvolvimento farmacêutico tradicional, além de internacionalizar o mercado
brasileiro. Na sistemática QbD apresenta-se elementos responsáveis por direcionar o racional
dos estudos necessários e quantidade de experimentos a serem realizados, e são considerados
como fortes critérios para aceitação de algum risco previsto.
The Quality by Design (QbD) study covers a systematic model of pharmaceutical development and it is based on studies and technical-scientific knowledge aligned with the risk management and is associated with the product and process pharmaceuticals. This study is conceptualized and applied in several places in the world and brings several benefits to the pharmaceutical industries for launching new drugs and maintaining products already in the market. In national companies, this concept is being increasingly discussed as it presents certain advantage in relation to the traditional pharmaceutical development, in addition to internationalizing the Brazilian market. In the QbD systematic, it is presented elements that are responsible for directing the rationale of necessary studies and the number of experiments to be carried out and are considered as strong criteria for accepting some predicted risk.
The Quality by Design (QbD) study covers a systematic model of pharmaceutical development and it is based on studies and technical-scientific knowledge aligned with the risk management and is associated with the product and process pharmaceuticals. This study is conceptualized and applied in several places in the world and brings several benefits to the pharmaceutical industries for launching new drugs and maintaining products already in the market. In national companies, this concept is being increasingly discussed as it presents certain advantage in relation to the traditional pharmaceutical development, in addition to internationalizing the Brazilian market. In the QbD systematic, it is presented elements that are responsible for directing the rationale of necessary studies and the number of experiments to be carried out and are considered as strong criteria for accepting some predicted risk.