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Dear Friends,
Can anybody suggest me with appropriate SAS Code or Proc or any help
in calculating following:
Model Independent Multivariate Confidence Region Procedure. Steps are
as follows:
1. Determine the similarity limits in terms of multivariate
statistical distance (MSD) based on interbatch differences in
dissolution from reference (standard approved) batches.
2. Estimate the MSD between the test and reference mean dissolutions.
3. Estimate 90% confidence interval of true MSD between test and
reference batches.
4. Compare the upper limit of the confidence interval with the
similarity limit.
This is a Model independent approach suggested in FDA Guidance
"Dissolution Testing of Immediate Release Solid Oral Dosage Forms".
Thanks in advance.
Regards,
Vikesh S
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