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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs

by Szapacs, Matt, Jian, Wenying, Spellman, Daniel, Cunliffe, Jennifer, Verburg, Elizabeth, Kaur, Surinder, Kellie, John, Li, Wenkui, Mehl, John, Qian, Mark, Qiu, Xiazi, Sirtori, Federico Riccardi, Rosenbaum, Anton I., Sikorski, Tim, Surapaneni, Sekhar, Wang, Jian, Wilson, Amanda, Zhang, Jinhui, Xue, Yongjun, Post, Noah, Huang, Yue, Goykhman, Dina, Yuan, Long, Fang, Kasie, Casavant, Ellen, Chen, Linzhi, Fu, Yunlin, Huang, Ming, Ji, Allena, Johnson, Jay, Lassman, Michael, Li, Jing, Saad, Ola, Sarvaiya, Hetal, Tao, Lin, Wang, Yuting, Zheng, Naiyu, Dasgupta, Arindam, Abhari, Mohsen Rajabi, Ishii-Watabe, Akiko, Saito, Yoshiro, Mendes Fernandes, Dulcyane Neiva, Bower, Joseph, Burns, Chris, Carleton, Kevin, Cho, Seongeun (Julia), Du, Xiulian, Fjording, Marianne, Garofolo, Fabio, Kar, Sumit, Kavetska, Olga, Kossary, Elham, Lu, Yang, Mayer, Andrew, Palackal, Nisha, Salha, Danielle, Thomas, Eric, Verhaeghe, Tom, Vinter, Stephen, Wan, Katty, Wang, Yow-Ming, Williams, Kathi, Woolf, Eric, Yang, Li, Yang, Eric, Bandukwala, Abbas, Hopper, Shirley, Maher, Kevin, Xu, Joshua, Brodsky, Eric, Cludts, Isabelle, Irwin, Chad, Joseph, Julie, Kirshner, Susan, Manangeeswaran, Mohanraj, Maxfield, Kimberly, Pedras-Vasconcelos, Joao, Solstad, Therese, Thacker, Seth, Tounekti, Omar, Verthelyi, Daniela, Wadhwa, Meenu, Wagner, Leslie, Yamamoto, Takenori, Zhang, Lucia, Zhou, Lin
Published in Bioanalysis (01.08.2023)

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization

by Sumner, Giane, Keller, Steve, Huleatt, James, Staack, Roland F, Wagner, Leslie, Azadeh, Mitra, Bandukwala, Abbas, Cao, Liching, Du, Xiulian, Salinas, Gabriela Franco, Garofolo, Fabio, Harris, Shannon, Hopper, Shirley, Irwin, Chad, Ji, Qin, Joseph, Julie, King, Lindsay, Kinhikar, Arvind, Lu, Yang, Luo, Rosa, Mabrouk, Omar, Malvaux, Ludovic, Marshall, Jean-Claude, McGuire, Kristina, Mikol, Vincent, Neely, Robert, Qiu, Xiazi, Saito, Yoshiro, Salaun, Bruno, Scully, Ingrid, Smeraglia, John, Solstad, Therese, Stoop, Jeroen, Tang, Huaping, Teixeira, Priscila, Wang, Yixin, Wright, Mike, Mendez, Luis, Beaver, Chris, Eacret, Jacqueline, Au-Yeung, Amelia, Decman, Vilma, Dessy, Francis, Eck, Steven, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Grugan, Katharine, Hedrick, Michael Nathan, Kar, Sumit, Sehra, Sarita, Stevens, Erin, Stevens, Chad, Sun, Yongliang, McCush, Fred, Williams, LaKenya, Fischer, Sally, Wu, Bonnie, Jordan, Gregor, Burns, Chris, Cludts, Isabelle, Coble, Kelly, Grimaldi, Christine, Henderson, Neil, Joyce, Alison, Lotz, Gregor, Lu, Yanmei, Luo, Linlin, Neff, Florian, Sperinde, Gizette, Stubenrauch, Kay-Gunnar, Wang, Yuting, Ware, Mark, Xu, Weifeng
Published in Bioanalysis (01.08.2023)

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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunoge

by Baratta, Mike, Jian, Wenying, Hengel, Shawna, Kaur, Surinder, Cunliffe, Jennifer, Boer, Jason, Hughes, Nicki, Kar, Sumit, Kellie, John, Kim, Yeoun Jin, Lassman, Michael, Mehl, John, Morgan, Ling, Palandra, Joe, Sarvaiya, Hetal, Zeng, Jianing, Zheng, Naiyu, Wang, Jian, Yuan, Long, Ji, Allena, Kochansky, Christopher, Tao, Lin, Huang, Yue, Maes, Estelle, Barbero, Luca, Contrepois, Kevin, Ferrari, Luca, Fu, Yunlin, Johnson, Jay, Jones, Barry, Kansal, Monika, Lu, Yang, Post, Noah, Shen, Honglue Holly, Xue, Yongjun Y-J, Zhang, Yiyue Cynthia, Biswas, Gopa, Cho, Seongeun Julia, Edmison, Anna, Benson, Kimberly, Abberley, Lee, Azadeh, Mitra, Francis, Jennifer, Garofolo, Fabio, Gupta, Shalini, Ivanova, Iordanka Dany, Ishii-Watabe, Akiko, Karnik, Shane, Kassim, Sean, Kavetska, Olga, Keller, Steve, Kossary, Elham, Li, Wenkui, McCush, Fred, Mendes, Dulcyane Neiva, Abhari, Mohsen Rajabi, Scheibner, Kara, Sikorski, Timothy, Staack, Roland F, Tabler, Edward, Tang, Huaping, Wan, Katty, Wang, Yow-Ming, Whale, Emma, Yang, Li, Zimmer, Jennifer, Bandukwala, Abbas, Du, Xiulian, Kholmanskikh, Olga, Gijsel, Sonja Kwadijk-de, Wadhwa, Meenu, Xu, Joshua, Buoninfante, Alessandra, Cludts, Isabelle, Diebold, Sandra, Maxfield, Kimberly, Mayer, Christian, Pedras-Vasconcelos, Joao, Shubow, Sophie, Tanaka, Yoichi, Tounekti, Omar, Verthelyi, Daniela, Wagner, Leslie
Published in Bioanalysis (02.05.2024)

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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

by Kholmanskikh, Olga, Wang, Yow-Ming, Hersey, Sarah, Wadhwa, Meenu, Block, Katherine, Bandukwala, Abbas, Szapacs, Matthew, Weiner, Russell, Awwad, Khader, Dessy, Francis, Downing, Sean, Du, Xiulian, Garofolo, Fabio, Harris, Shannon, Hou, Victor, Jones, Jennifer, Kar, Sumit, Kinhikar, Arvind, Li, Ming, Mathews, Joel, Meissen, John, Sumner, Giane Oliveira, Pan, Luying, Sanderink, Gerard, Scully, Ingrid, Stanta, Johannes, Tanaka, Yoichi, Vauleon, Stephanie, Wagner, Leslie, Wang, Kai, Zhu, Liang, Eck, Steven, Lin, Yi-Dong, Azadeh, Mitra, Decman, Vilma, Diebold, Sandra, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Hedrick, Michael Nathan, Hopkins, Gregory, Loschko, Jakob, McCausland, Megan, Mendez, Luis, Sehra, Sarita, Stevens, Erin, Sun, Yongliang Steve, Tangri, Shabnam, Trampont, Paul C, Cludts, Isabelle, Dysinger, Mark, Kavita, Uma, Sugimoto, Hiroshi, Chilewski, Shannon, Grimaldi, Christine, Jiang, Yong, Kamerud, John, Liu, Susana, Owen, Carolina, Palackal, Nisha, Petit-Frere, Corinne, Pine, Samuel, Abhari, Mohsen Rajabi, Scheibner, Kara, Williams, LaKenya, Xu, Tao, Zhang, Guodong
Published in Bioanalysis (17.04.2024)

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