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Dear Roger, Laxman and All,
Thanks for the responses.
I have few more queries and will be happy to have them clarified.
1. Bioanalytical method development/ validation should be performed
using DRUG SUBSTANCE or DRUG PRODUCT?
2. For assessing accuracy which of the two statement best satisfies
the requirement stated in the guideline?
(a) Assessment of five (5) individually prepared samples (per
concentration) or (b) Five (5) assessments of a single homogenous
sample (per concentration).
3. In 4-PL curve fit model, what is the acceptable variation, in terms
of %CV for the four parameters (A, B, C and D)? On two different days
of sample analysis, if these parameters vary more than 20 % can the
sample results be considered reliable?
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