How to calculate Tow one-sided t-tests with intersite (receiving & transferring)differences ≤ 10%,95% confidence for residual solvents by GC - HSS (n=8, 4 for receiving and 4 for transferring sites) for analytical method transfer. Whether this t-test mentioned in the guidelines referes to Schuirmanns TOST.
if so, whether the ≤ 10%, spceification is upper and lower limit.
results were failying w.r.to GC OVI analysis hence the % SD is about 25% for one side and about 10.5 for the other side. as per the guidelines we have presumed that one side n=4, hence performed the TOST taking n=8.
Hi Thomas, Thanks for your response, the requirement as per the WHO guidelines is (TOST) and not two sided t test (student t test), and the n also only 4 for impurity.we need to implement as per the guidelines.
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