Regulated bioanalysis: an Indian perspective on harmonization efforts

“The Indian bioanalytical community is poised to seize this opportunity to participate and adopt an internationally harmonized bioanalytical guideline.” Bioanalysis is today performed in far-flung parts of the globe. Regional differences exist in guideline requirements, and their correct and complete interpretation in a laboratory setting has proven to be a challenge. There is now a growing voice from bioanalytical opinion leaders, regulators and the research community supporting the creation of a single internationally harmonized guideline for bioanalysis. The recently formed Global Bioanalysis Consortium aims to create a unified consensus bioanalytical guidance that would be acceptable to regulatory agencies globally. This...

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