Regulated bioanalysis: an Indian perspective on harmonization efforts
A wireless microphone lying on a white table against the background of the DSLR camera to led light.
“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...
