Chega-se à conclusão que, nos moldes propostos nesse estudo, a averiguação de bioequivalência de valproato de sódio foi considerada segura e apresentou satisfatória tolerabilidade, em ambas formulações.
O valproato de sódio na formulação teste possui bioequivalência frente a formulação referência, quando observados taxa, extensão da absorção e velocidade de absorção, visto o intervalo de confiança de 90% frente à razão individual para ASCultimo,
ASCinf e Cmax, contemplados no intervalo entre 80 a 125%, conforme regulamentações da
FDA e ANVISA.
Por fim, conclui-se ainda que posições negativas para substituição de medicamento genérico de valproato de sódio frente ao medicamento referência não encontram fundamentação sólida quando utilizado a justificativa de que tais tipos de medicamentos não apresentam bioequivalência, ao menos ao que se refere aos componentes deste estudo.
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8. ANEXOS
Anexo III: Termo de Recrutamento
TERMO DE RECRUTAMENTO
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