Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

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 and ISR. 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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