Literature DB >> 21679026

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

Steve Lowes1, Jim Jersey, Ronald Shoup, Fabio Garofolo, Natasha Savoie, Ejvind Mortz, Shane Needham, Maria Cruz Caturla, Ray Steffen, Curtis Sheldon, Roger Hayes, Tim Samuels, Lorella Di Donato, John Kamerud, Steve Michael, Zhongping John Lin, Jim Hillier, Marc Moussallie, Leonardo de Souza Teixeira, Mario Rocci, Mike Buonarati, James Truog, Saleh Hussain, Richard Lundberg, Alan Breau, Tianyi Zhang, Jianine Jonker, Neil Berger, Sofi Gagnon-Carignan, Corey Nehls, Robert Nicholson, Martijn Hilhorst, Shane Karnik, Theo de Boer, Richard Houghton, Kirk Smith, Laura Cojocaru, Mike Allen, Tammy Harter, Saadya Fatmi, Farhad Sayyarpour, Jenifer Vija, Michele Malone, Dennis Heller.   

Abstract

"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

Mesh:

Year:  2011        PMID: 21679026     DOI: 10.4155/bio.11.135

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  4 in total

Review 1.  Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team.

Authors:  Nico van de Merbel; Natasha Savoie; Manish Yadav; Yoshiaki Ohtsu; Joleen White; Maria Francesca Riccio; Kelly Dong; Ronald de Vries; Julie Diancin
Journal:  AAPS J       Date:  2014-02-19       Impact factor: 4.009

2.  Quantification and validation of ertapenem using a liquid chromatography-tandem mass spectrometry method.

Authors:  S P van Rijn; A M A Wessels; B Greijdanus; D J Touw; J W C Alffenaar
Journal:  Antimicrob Agents Chemother       Date:  2014-04-14       Impact factor: 5.191

3.  Comparison of LC-MS/MS and EMIT methods for the precise determination of blood sirolimus in children with vascular anomalies.

Authors:  Yue-Tao Zhao; Hao-Ran Dai; Yue Li; Yuan-Yuan Zhang; Hong-Li Guo; Xuan-Sheng Ding; Ya-Hui Hu; Feng Chen
Journal:  Front Pharmacol       Date:  2022-09-06       Impact factor: 5.988

4.  Determination of Anlotinib, a Tyrosine Kinase Inhibitor, in Rat Plasma by UHPLC-MS/MS and Its Application to a Pharmacokinetic Study.

Authors:  Zhe Wang; Le-Jing Lian; Yan-Yan Dong; Xiao Cui; Jian-Chang Qian; Cheng-Ke Huang; Rui-Jie Chen; Wei Sun
Journal:  J Anal Methods Chem       Date:  2019-12-10       Impact factor: 2.193

  4 in total

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