9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

Bioanalysis ·第 8 卷 ·第 6 期 ·0000-00-00

Hayes Roger, LeLacheur Richard, Dumont Isabelle, Couerbe Philippe, Safavi Afshin, Islam Rafiq, Pattison Colin, Cape Stephanie, Rocci Mario, Briscoe Chad, Cojocaru Laura, Groeber Elizabeth, Silvestro Luigi, Bravo Jennifer, Shoup Ron, Verville Manon, Zimmer Jennifer, Caturla Maria Cruz, Khadang Ardeshir, Bourdage James, Hughes Nicola, Fatmi Saadya, Di Donato Lorella, Sheldon Curtis, Keyhani Anahita, Satterwhite Christina, Yu Mathilde, Fiscella Michele, Hulse James, Lin Zhongping John, Garofolo Wei, Savoie Natasha, Xiao Yi Qun, Kurylak Kai, Harris Sarah, Saxena Manju, Buonarati Mike, Lévesque Ann, Boudreau Nadine, Lin Jenny, Khan Masood U, Ray Gene, Liu Yansheng, Xu Allan, Soni Gunjan, Ward Ian, Kingsley Clare, Ritzén Hanna, Tabler Edward, Nicholson Bob, Bennett Patrick, van de Merbel Nico, Karnik Shane, Bouhajib Mohammed, Wieling Jaap, Mulvana Daniel, Ingelse Benno, Allen Mike, Malone Michele, Fang Xinping

摘要

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

关键词

biomarker biosimilar blood partitioning

文献信息

期刊

Bioanalysis

期刊简称

Bioanalysis

ISSN

1757-6180

DOI

10.4155/bio.16.16

发表日期

0000-00-00

收录日期

2016-03-04

更新日期

2016-03-04

语言

英语

国家/地区

England

NLM ID

101512484

外部链接

PubMed 原文 DOI: 10.4155/bio.16.16 查看期刊详情

分析服务

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

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