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Guidance from various regulatory authorities has helped significantly in the
standardization of how to approach about regulated quantitative bioanalysis
of small molecules. However there are some interpretation differences which
are leading to dissimilar practices among bioanalytical scientists. Good scientific
rationality must exist and assessment performed should be case specific.
There are many hot topics viz, Ion Suppression, Matrix Effect, Contamination
Criteria, multi analytes, failed run investigation, Regression Type, Stability, Repeats
Impact of above said areas on outcome of the bioequivalence study was incorporated
in the current presentation in the form of case studies.
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