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首页> 外文期刊>Bioanalysis >2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1-small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)
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2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1-small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

机译：2018年白皮书关于生物分析的最近问题：'全球生物分析群落的前几十年的攻击性排雷（ISR）'（第1部分 - 小分子调节生物分析，小分子生物标志物，肽和寡核苷酸生物分析）

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The 2018 12th Workshop on Recent Issues in Bioanalysis (12th WRIB) took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LC-MS, hybrid ligand binding assay (LBA)/LC-MS and LBA/cell-based assays approaches. This 2018 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. Due to its length, the 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for LC-MS for small molecules, peptides, oligonucleotides and small molecule biomarkers. Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays) are published in volume 10 of Bioanalysis, issues 23 and 24 (2018), respectively.
机译：2018年第12次讲习班关于生物分析的最近问题（第12条腕表）在2018年4月9日至33日在美国Pa，Pa，Pa，Pa，Pa，Pa，Pa，Pharmicalical / Biopharmaceutical公司，生物技术公司，合同研究组织和监管机构出席了900多名代表全世界。 WRIB再次进行5天的浸入生物分析，生物标志物和免疫原性。像往常一样，它专门旨在促进分享，审查，讨论和同意解决最新利益问题的方法，包括涉及LC-MS，杂交配体结合测定（LBA）/ LC-的小型和大分子生物分析基于MS和基于LBA /细胞的测定方法。本2018年白皮书包括从研讨会期间举行的广泛讨论中出现的建议，并旨在为生物分析社区提供关键信息和解决主题和问题的实际解决方案，以便在卓越的科学卓越，提高质量和更好的提高法规遵从性。由于其长度，2018年全面的白皮书被分为三个部分，因为编辑原因。本出版物（第1部分）涵盖了对小分子，肽，寡核苷酸和小分子生物标志物的LC-MS的建议。第2部分（用于生物治疗和监管机构的投入的杂交LBA / LC-MS）和第3部分（使用LBA和细胞的测定的大分子生物分析，生物标志物和免疫原性）发表于生物分析的10卷，问题23和24（2018年）， 分别。

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