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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)
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| Published in: | Bioanalysis 2024, Vol.16 (8), p.179-220 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| container_end_page | 220 |
| container_issue | 8 |
| container_start_page | 179 |
| container_title | Bioanalysis |
| container_volume | 16 |
| creator | 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 |
| description | |
| doi_str_mv | 10.1080/17576180.2024.2340961 |
| format | article |
| fullrecord | 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| fulltext | fulltext |
| identifier | ISSN: 1757-6180 |
| ispartof | Bioanalysis, 2024, Vol.16 (8), p.179-220 |
| issn | 1757-6180 1757-6199 |
| language | eng |
| recordid | cdi_crossref_primary_10_1080_17576180_2024_2340961 |
| source | PubMed Central |
| title | 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) |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-22T16%3A16%3A45IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-crossref&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=2023%20White%20Paper%20on%20Recent%20Issues%20in%20Bioanalysis:%20EU%20IVDR%202017/746%20Implementation/Impact,%20IVD/CDx/CLIA%20Approved%20Assays,%20High%20Dimensional%20Cytometry,%20Multiplexing%20Technologies,%20LBA%20Tissue%20Analysis,%20Vaccine%20Study%20Endpoints,%20Cell-Based%20Assays%20for%20Biomarkers,%20Cell%20Therapy%20and%20Vaccines%20(%20PART%C2%A02%20%E2%80%93%20Recommendations%20on%20Development%20&%20Validation%20of%20Biomarkers,%20IVD,%20CDx,%20Cell-Based,%20Flow%20Cytometry,%20Ligand-Binding%20and%20Enzyme%20Assays;%20Advanced%20Critical%20Reagents%20Strategies)&rft.jtitle=Bioanalysis&rft.au=Kholmanskikh,%20Olga&rft.date=2024&rft.volume=16&rft.issue=8&rft.spage=179&rft.epage=220&rft.pages=179-220&rft.issn=1757-6180&rft.eissn=1757-6199&rft_id=info:doi/10.1080/17576180.2024.2340961&rft_dat=%3Ccrossref%3E10_1080_17576180_2024_2340961%3C/crossref%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c304t-2dc27ee1883b2b9d4178405129c2084c3f17baa8d12b4f99daf6933dce9fa7383%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_id=info:pmid/&rfr_iscdi=true |