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Request Your Free White Paper Now:
"Strategies to Improve Comparability Assessments Across Bioanalytical Data for Biosimilar Studies"
White Paper: Strategies to Improve Comparability Assessments Across Bioanalytical Data for Biosimilar Studies
Experts in bioanalysis, Gwen Eak and Kelli Phillips of PPD, part of Thermo Fisher Scientific outline the evolution of biosimilar drug development regulations in the last two decades, giving background on harmonization efforts in the US and EU and key milestones, as well as delving into key areas specific to bioanalysis in biosimilar programs including:
- Method development and validation
- Immunogenicity assays
- PK considerations
- Comparability assessment
Offered Free by: PPD Labs
See All Resources from: PPD Labs
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