論文

国際誌
2016年12月

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

Bioanalysis
  • Susan Richards
  • Lakshmi Amaravadi
  • Renuka Pillutla
  • Herbert Birnboeck
  • Albert Torri
  • Kyra J Cowan
  • Apollon Papadimitriou
  • Fabio Garofolo
  • Christina Satterwhite
  • Steven Piccoli
  • Bonnie Wu
  • Corinna Krinos-Fiorotti
  • John Allinson
  • Flora Berisha
  • Laurent Cocea
  • Stephanie Croft
  • Stephanie Fraser
  • Fabrizio Galliccia
  • Boris Gorovits
  • Swati Gupta
  • Vinita Gupta
  • Sam Haidar
  • Charles Hottenstein
  • Akiko Ishii-Watabe
  • Darshana Jani
  • John Kadavil
  • John Kamerud
  • Daniel Kramer
  • Virginia Litwin
  • Gustavo Mendes Lima Santos
  • Robert Nelson
  • Yan Ni
  • João Pedras-Vasconcelos
  • Yongchang Qiu
  • Paul Rhyne
  • Afshin Safavi
  • Yoshiro Saito
  • Natasha Savoie
  • Kara Scheibner
  • Eginhard Schick
  • Patricia Y Siguenza
  • John Smeraglia
  • Roland F Staack
  • Meena Subramanyam
  • Giane Sumner
  • Theingi Thway
  • David Uhlinger
  • Martin Ullmann
  • Alessandra Vitaliti
  • Jan Welink
  • Chan C Whiting
  • Li Xue
  • Rong Zeng
  • 全て表示

8
23
開始ページ
2475
終了ページ
2496
記述言語
英語
掲載種別
研究論文(学術雑誌)

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th 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 weeklong event - A Full Immersion Week of Bioanalysis for PK, 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 PK, 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 3) discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Parts 1 (small molecule bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

リンク情報
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/27855512
ID情報
  • eISSN : 1757-6199
  • PubMed ID : 27855512

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