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Bioanalysis|August 10, 2021
COVID-19's impact on bioanalytical labsAmy Lavelle, Janine Micheli
The AAPS Journal|October 24, 2020
Women in the Pharmaceutical Sciences: Honoring Our PioneersAmy Lavelle, Marilyn E Morris
Bioanalysis|April 29, 2020
Strategies for method comparison when changes in the immunogenicity method are needed within a clinical programJohanna R Mora, Joleen T White, Shannon D Chilewski, et al.
The AAPS Journal|January 8, 2026
Anti-drug Antibody Validation Testing and Reporting Harmonization AddendumHeather Myler, Johanna Mora, Joao Pedras-Vasconcelos, et al.
The AAPS Journal|July 26, 2024
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry PracticesArvind Kinhikar, Mohamed Hassanein, Jake Harman, et al.
Bioanalysis|June 12, 2024
16<sup>th</sup> GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry statusJennifer Zimmer, Amanda Hays, Todd Lester, et al.
The AAPS Journal|September 19, 2025
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCRJason Pennucci, Amanda Hays, Wendy Adamowicz, et al.
The AAPS Journal|July 8, 2023
Neutralizing Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Todd Lester, et al.
Bioanalysis|April 18, 2025
Recommendations on biomarker assay validation (BAV) in tissues by GCCMoucun Yuan, Aihua Liu, Bin Xu, et al.
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