S

Susan Kirshner

United States Food and Drug Administration

4 papers and 204 citations.

4Publications
204Total Citations

Top publicationsby citations

2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp &amp; Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity &amp; Technologies; Immunogenicity &amp; Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan, Swati Gupta, Johanna Mora et al.|Bioanalysis|2023
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