Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

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.

Biography