East-west Global Initiatives In Regulated R&D Programs | 18745
Journal of Analytical & Bioanalytical Techniques
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Pharmaceutical industry has led global initiatives to develop consensus around acceptable benchmark practices applicable
to standardizing laboratory and good management systems for regulated R&D programs. Collaboration between West
and East has become increasingly important for the quality of data, implementations, and products approved for public use
by regulatory agencies worldwide. In this presentation, historical background and current progress on regulated bioanalysis
for preclinical and clinical research will be discussed. Ongoing activities regarding continuous improvement of quality from
technical and regulatory perspectives will be described using typical case studies (i.e., how to establish robust and high quality
bioanalytical methods based on emerging techniques and approaches). The presentation will conclude by outlining future
trends in this field for which successful implementation and execution is expected to improve quality and consistency for
clinical bioanalysis from global perspectives.
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