2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (<u>Part 2A</u> – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation <u>Part 2B</u> – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

MLA

Andrew P Mayer, et al. “2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).” Bioanalysis, vol. 13, Mar. 2021, pp. 295–361. EBSCOhost, https://doi.org/10.4155/bio-2021-0005.

APA

Andrew P Mayer, Jinhui Zhang, Sam Haidar, Sandra Nuti, Shyam Sarikonda, Therese Solstad, Megan McCausland, Fabian Junker, Elana Cherry, Susan M. Spitz, Tahseen Mirza, Anna Edmison, Patrick Faustino, Yan Zhang, Rafiq Islam, Steven Eck, Christèle Gonneau, Fabio Garofolo, Nilufer Tampal, … Abbas Bandukwala. (2021). 2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis, 13, 295–361. https://doi.org/10.4155/bio-2021-0005

Chicago

Andrew P Mayer, Jinhui Zhang, Sam Haidar, Sandra Nuti, Shyam Sarikonda, Therese Solstad, Megan McCausland, et al. 2021. “2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).” Bioanalysis 13 (March): 295–361. doi:10.4155/bio-2021-0005.