Analytical method bridging study strategy survey

Following a review of the Analytical method bridging benchmarking survey results, key messages appear to be that:

  • Bridging approaches differ from company to company
  • There seems to be a lack of a harmonized approach outside of the commercial setting.

The team feel there is a gap in this area that needs a standardized perspective, particularly in the pre-BLA space. A smaller group within the workstream have performed a literature review and are currently performing a gap analysis to ascertain if a guidance paper would be beneficial and what the scope of this would be.

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