2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies)
The 2016 10th Workshop on Recent Issues in Bioanalysis (10 WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once...
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| Veröffentlicht in: | Bioanalysis 2016-12, Vol.8 (23), p.2457-2474 |
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| creator | Song, An Lee, Anita Garofolo, Fabio Kaur, Surinder Duggan, Jeff Evans, Christopher Palandra, Joe Donato, Lorella Di Xu, Keyang Bauer, Ronald Bustard, Mark Chen, Linzhi Cocea, Laurent Croft, Stephanie Galliccia, Fabrizio Haidar, Sam Hughes, Nicola Ishii-Watabe, Akiko Islam, Rafiqul Jones, Barry Kadavil, John Krantz, Carsten Lima Santos, Gustavo Mendes Olah, Timothy Pedras-Vasconcelos, João Staelens, Ludovicus Saito, Yoshiro Savoie, Natasha Scheibner, Kara Spitz, Susan Tampal, Nilufer Thomas, Eric Vinter, Stephen Wakelin-Smith, Jason Welink, Jan Zeng, Jianing Zhou, Shaolian |
| description | The 2016 10th Workshop on Recent Issues in Bioanalysis (10
WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 2) discusses the recommendations for Hybrid LBA/LCMS and regulatory inputs from major global health authorities. Parts 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) have been published in the
journal, issues 22 and 23, respectively. |
| doi_str_mv | 10.4155/bio-2016-4988 |
| format | Article |
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WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 2) discusses the recommendations for Hybrid LBA/LCMS and regulatory inputs from major global health authorities. Parts 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) have been published in the
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journal, issues 22 and 23, respectively.</description><subject>Antibodies, Anti-Idiotypic - analysis</subject><subject>Antibodies, Anti-Idiotypic - immunology</subject><subject>Biomarkers - analysis</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Consensus Development Conferences as Topic</subject><subject>Government Agencies</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Ligands</subject><subject>Mass Spectrometry</subject><subject>Validation Studies as Topic</subject><issn>1757-6180</issn><issn>1757-6199</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMtOwzAQRS0EgqqwZItm2S4Ccd7urq2AIhVRidcymjhjMLRJZSdI-RW-FkeF7vBmbM-5M7qXsXPuX0Y8jq8KXXuBzxMvEll2wAY8jVMv4UIc7u-Zf8LOrP3w3QmDTETimJ0EaRbHsS8G7LuXw-u7bghWuCUDdQWGJFUNaGtbsqArcHuwwnVntZ2AqmVre8z9btB8Og1aix184VqX2GjXGs2mL-MJjFZoGgjAg0VXGF3Ccja9Ws7vHwGr0g3etg0oU2_cxrd2jU1tOsA3qqQmOz5lRwrXls5-65A931w_zRfe8uH2bj5dejKMROOhChWmvhBBqBJybrIklVySS4QnVEZplqWhK1j03SLlZZGIIiaM4jAsFIZD5u3mSlNba0jlW6OdsS7nft7HnDujeZ9T3sfs-Isdv22LDZV7-i9UB4gdoNqmNWSdm0pSvns5hZa6on-G_wCVdouP</recordid><startdate>20161201</startdate><enddate>20161201</enddate><creator>Song, An</creator><creator>Lee, Anita</creator><creator>Garofolo, Fabio</creator><creator>Kaur, Surinder</creator><creator>Duggan, Jeff</creator><creator>Evans, Christopher</creator><creator>Palandra, Joe</creator><creator>Donato, Lorella Di</creator><creator>Xu, Keyang</creator><creator>Bauer, Ronald</creator><creator>Bustard, Mark</creator><creator>Chen, Linzhi</creator><creator>Cocea, Laurent</creator><creator>Croft, Stephanie</creator><creator>Galliccia, Fabrizio</creator><creator>Haidar, Sam</creator><creator>Hughes, Nicola</creator><creator>Ishii-Watabe, Akiko</creator><creator>Islam, Rafiqul</creator><creator>Jones, Barry</creator><creator>Kadavil, John</creator><creator>Krantz, Carsten</creator><creator>Lima Santos, Gustavo Mendes</creator><creator>Olah, Timothy</creator><creator>Pedras-Vasconcelos, João</creator><creator>Staelens, Ludovicus</creator><creator>Saito, Yoshiro</creator><creator>Savoie, Natasha</creator><creator>Scheibner, Kara</creator><creator>Spitz, Susan</creator><creator>Tampal, Nilufer</creator><creator>Thomas, Eric</creator><creator>Vinter, Stephen</creator><creator>Wakelin-Smith, Jason</creator><creator>Welink, Jan</creator><creator>Zeng, Jianing</creator><creator>Zhou, Shaolian</creator><general>Future Science Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20161201</creationdate><title>2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies)</title><author>Song, An ; 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| fulltext | fulltext |
| identifier | ISSN: 1757-6180 |
| ispartof | Bioanalysis, 2016-12, Vol.8 (23), p.2457-2474 |
| issn | 1757-6180 1757-6199 |
| language | eng |
| recordid | cdi_crossref_primary_10_4155_bio_2016_4988 |
| source | MEDLINE; PubMed Central |
| subjects | Antibodies, Anti-Idiotypic - analysis Antibodies, Anti-Idiotypic - immunology Biomarkers - analysis Chromatography, High Pressure Liquid Consensus Development Conferences as Topic Government Agencies Humans Immunoassay Ligands Mass Spectrometry Validation Studies as Topic |
| title | 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies) |
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