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  • Title: Bioequivalence study for diazepam commercial tablets in psychiatric patients.
    Author: Domínguez A, Cortés A, Cárdenas H, Galindo MC, Helgi JC.
    Journal: Arch Med Res; 1994; 25(1):23-7. PubMed ID: 8019110.
    Abstract:
    The bioequivalence of three different commercial diazepam tablets (5 mg) using the innovator product (Valium, Roche) as a reference was evaluated in eight psychiatric patients, following a multiple-dose regimen (5 mg t.i.d.). Each patient received the four treatments sequentially according to a Latin square design, with balance for first residual effect. Blood samples were taken once the steady state of the drug had been reached, and the plasma levels were determined using a HPLC method. No statistical differences were found in diazepam steady-state levels after the administration of the four formulations, indicating that they could be considered equivalent.
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