To which dosage I should the complete Analytic Method validation
A product I have been handling has 6 strengths of 5mg, 20mg, 50mg,100mg and 250mg of Dose Proportional and one is likely dose (Pseudo Dose) of 500mg with 250mg.
To which dosage I should the complete Analytic Method validation?
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In general, When we have multiple strengths, we will do total validation for Lower strenght however all the strengths are included in Method Precision.
The reason is that the assumption that if we gets the Assay for the Lower strenght or the Lower proportion of API in Pseudo Dose, it is easier to get recovery for higher strengths.
So, for this assumption, we generally do Full validation for the Lower Strenght.
Here, we should think that However Placebo is not reacting and sometimes it will enhance the Assay of API, the amount of Placebo may impact the Recovery as to nullify the condition, we go for Lower proportion or the Lower strenght for the validation.