Aplicação de métodos quimiométricos em estudos de bioequivalência do antibiótico amoxicilina

• Ano de defesa: 2008
• Autor(a) principal: Ramos, Douglas Rodrigues
• Orientador(a): Souza, Paulo Sérgio de
• Banca de defesa: Souza, Paulo Sérgio de, Garrote, Clévia Ferreira Duarte, Coelho, Clarimar José
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de Goiás
• Programa de Pós-Graduação: Programa de Pós-graduação em Química (IQ)
• Departamento: Instituto de Química - IQ (RG)
• País: Brasil
• Palavras-chave em Português: Quimiometria; Bioequivalência; Amoxicilina; Componentes principais e análise hierárquica
• Palavras-chave em Inglês: Chemometrics; Bioequivalence; Amoxicillin; Principal components and hierarchical analysis
• Área do conhecimento CNPq: CIENCIAS EXATAS E DA TERRA::QUIMICA
• Link de acesso: http://repositorio.bc.ufg.br/tede/handle/tede/8724

The generic medicines have brought to the national population a higher possibility to access the treatment with medication, the competition stimulation and the medicine exchange insertion, in which the reference formulation can be substituted by the generic medicine, without any harm to the treatment. ANVISA (National Agency of Sanitary Surveillance) regulates this national market, demanding the bioequivalence confirmation between test and reference medicines. Therefore, in a period of six years, those studies have been performed and several generic medicines have been liberated to commercialization. However, the exchange confirmation among the several generic and reference medication are still difficult to observe due to the complexity of the values obtained. The chemometrics analysis decreases the sample space of the complex data which allows samples similarity observation as well as their classification in distinct groups. For that, Principal Components Analysis (PCA) and the Hierarchical Cluster Analysis (HCA) have been used. With these techniques an n-dimension space statistics have been evaluated for a bi-dimension of six amoxicillin bioequivalence studies as capsules and suspensions and therefore, classified them in groups in accordance with the similarity of the formulations pharmacokinetic profiles, which has allowed the medicine exchange observation. The chemometrics applications in pharmacokinetic data differentiated the pharmaceuticals forms capsule and suspensions, of absorption and elimination parameters allowing the exchange avaliations of formulations showing been useful in research laboratories or by regulatories agency for the quality monitoring of the medicine.