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Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data

Hugo Hamel1, Hye-Na Kang2

  • 1Health Canada, Tunney's Pasture, A/L 0603C2, Ottawa, Canada.

Biologicals : Journal of the International Association of Biological Standardization
|November 1, 2019
PubMed
Abstract

Keywords:
Biotherapeutic productCase studyImplementation workshopPost-approval changeQuality changeWHO

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