16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J.
Zimmer J, et al. Among authors: patel v.
Bioanalysis. 2024 Jun 12:1-13. doi: 10.1080/17576180.2024.2342691. Online ahead of print.
Bioanalysis. 2024.
PMID: 38864397