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ANANBIOANAL - 2010
Pharmaceutical R & D Summit
doi:10.4172/2155-9872.1000099
Focus on Challenges in Regulated Bioanalysis; Case Studies
D. Vijaya Bharathi
Dr.Reddys Laboratories Limited, Hyderabad, India
G
uidance 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.
ANALBIOANAL-2010
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