Forming Bioanalytical and Immunogenicity Strategies that Support Biosimilar Product Development

Forming Bioanalytical and Immunogenicity Strategies that Support Biosimilar Product Development
Bonita (Bonnie) Rup of Bonnie Rup Consulting, discusses PK and Immunogenicity in BiotherapeuticDevelopment and Use, What regulatory guidancessay about bioanalysis/immunogenicity analysis, What to consider in selecting the right population for your study, How to incorporate assay data into the overall study design, How to effectively interpret and present bioanalytical and immunogenicity data, and Types of Issues that Should be Discussed with Regulators.

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