Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model.

Spleen dissemination was 0%, 40%, and 100% for innovator, generic, and the untreated control group, respectively, but the difference between innovator and generic did not reach statistical significance (P = 0.0867).

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All gentamicin products fitted Hill's model, which described their dose-effect relationships with an excellent fit, generating multicollinearity-free, highly significant PD parameters, and a nonlinear regression fulfilling the assumptions of normality, constant variance and independence ( Table 3 ).

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