Recommendations from the AAPS Biosimilars Committee for the Validation of Bioanalytical Methods in Support of Biosimilar Drug Development

  • At: 2017 FIP Congress in Seoul (South Korea)
  • Type: Presentation
  • By: GOUTY, Dominique (BioAgilytix, Business Operations, Durham, United States)
  • Co-author(s): Dominique Gouty
  • Abstract:

    When developing biosimilar drugs, it is critical to demonstrate biosimilarity to the originator drug including similarities of physical and chemical properties as well as Pharmacokinetic (PK) analyses. Proving the similarities can be challenging and developing PK and immunogenicity assays to demonstrate biosimilarity require specific steps in..

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