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| Author(s): |
Roberto Molina de Souza
Total Authors: 1
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| Document type: | Master's Dissertation |
| Press: | Ribeirão Preto. |
| Institution: | Universidade de São Paulo (USP). Faculdade de Medicina de Ribeirão Preto (PCARP/BC) |
| Defense date: | 2009-02-16 |
| Examining board members: |
Jorge Alberto Achcar;
Silvia Regina Costa Lopes;
Josmar Mazucheli
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| Advisor: | Jorge Alberto Achcar |
| Abstract | |
SOUZA, R. M. \\Statistics on Bioequivalence: Guarantee in quality of generic drug\". 2008. 42 s Dissertation (Master Degree) Faculdade de Medicina de Ribeir~ao Preto - USP As an alternative to medicines for human use of great movement in Brazil, the use of generic medicines were regulated, according to the law of the generic no 9787/99, which establish the studies of bioavailability and bioequivalence in Brazil in order to evaluate bioequivalence of generic formulations, considering as reference existing medicinal products, with proved ecacy. Two formulations of the same drug are considered bioequivalents if your bioavailability do not present evidence of signicant dierences according to clinically specied limits known as bioequivalence limits. Bioequivalence studies are carried out by the administration of two formulations (one is in test and the other one is the reference) in a pre-dened number of volunteers using an experimental plan that is often the crossover one. After the withdrawn of successive blood or urinary samples in predetermined intervals, some pharmacokinetic parameters were studied, such as area under concentration curve, maximum concentration of drug and time that the maximum concentration occurs. This dissertation introduces some basic concepts of bioequivalence and following that, it is presented Bayesian analysis for both as univariate and as multivariate bioequivalence measures assuming the multivariate normal distribution for the data and also the distribution of multivariate t student distribution. An application in order to illustrate what was introduced is presented in this work, and by using means of selection criteria of models, it was observed that for all data on study, there were evidences that lead to choose the multivariates models in order to conduct this study of average bioequivalence. (AU) | |
| FAPESP's process: | 07/01594-0 - Statistics on bioequivalence: guarantee in quality of generic drug |
| Grantee: | Roberto Molina de Souza |
| Support Opportunities: | Scholarships in Brazil - Master |