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RegisterPaliperidone palmitate study design [Design Issues]
Dear M.tareq,
the Draft Guidance on Paliperidone Palmitate Paliperidone states "Design: Parallel or crossover steady-state".
But: Paliperidone palmitate’s slow dissolution rate results in a half-life of 25 to 49 days. Thus I think a cross-over study isn't really feasible.
Thus go with a parallel-group study. Your doubts about intra-subject variabilities are gone. Use the total variability you have to estimate the sample size.
The evaluation model is then simply an ANOVA with the effects 'treatment' and 'injection site'.
the Draft Guidance on Paliperidone Palmitate Paliperidone states "Design: Parallel or crossover steady-state".
But: Paliperidone palmitate’s slow dissolution rate results in a half-life of 25 to 49 days. Thus I think a cross-over study isn't really feasible.
Thus go with a parallel-group study. Your doubts about intra-subject variabilities are gone. Use the total variability you have to estimate the sample size.
The evaluation model is then simply an ANOVA with the effects 'treatment' and 'injection site'.
—
Regards,
Detlew
Regards,
Detlew
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