Literature DB >> 21110739

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

Natasha Savoie1, Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver, Patrick Bedford, Brian P Booth, Christopher Evans, Mohammed Jemal, Marc Lefebvre, Arthur Leonardo Lopes de Silva, Steve Lowes, Joseph C Marini, Robert Massé, Louise Mawer, Eric Ormsby, Mario L Rocci, Ct Viswanathan, Jason Wakelin-Smith, Jan Welink, Joleen T White, Eric Woolf.   

Abstract

The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.

Mesh：

Substances：

Year:  2010        PMID： 21110739     DOI： 10.4155/bio.10.164

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


  4 in total

1.  Safety and tolerability of guadecitabine (SGI-110) in patients with myelodysplastic syndrome and acute myeloid leukaemia: a multicentre, randomised, dose-escalation phase 1 study.

Authors:  Jean-Pierre J Issa; Gail Roboz; David Rizzieri; Elias Jabbour; Wendy Stock; Casey O'Connell; Karen Yee; Raoul Tibes; Elizabeth A Griffiths; Katherine Walsh; Naval Daver; Woonbok Chung; Sue Naim; Pietro Taverna; Aram Oganesian; Yong Hao; James N Lowder; Mohammad Azab; Hagop Kantarjian
Journal:  Lancet Oncol       Date:  2015-08-19       Impact factor: 41.316

Review 2.  Toward sensitive and accurate analysis of antibody biotherapeutics by liquid chromatography coupled with mass spectrometry.

Authors:  Bo An; Ming Zhang; Jun Qu
Journal:  Drug Metab Dispos       Date:  2014-09-02       Impact factor: 3.922

3.  Introduction to the proposals from the global bioanalysis consortium harmonization team.

Authors:  Philip Timmerman; Mark Arnold; Binodh DeSilva; Fabio Garofolo; Michaela Golob; Peter van Amsterdam; Shinobu Kudoh; Puran Singhal; Daniel Tang; Maria Francesca Riccio; Rafael Barrientos; Shrinivas Savale; Tatsuo Kurokawa
Journal:  AAPS J       Date:  2014-10-02       Impact factor: 4.009

4.  Adding value to antiretroviral proficiency testing.

Authors:  Robin DiFrancesco; Charlene R Taylor; Susan L Rosenkranz; Kelly M Tooley; Poonam G Pande; Suzanne M Siminski; Richard W Jenny; Gene D Morse
Journal:  Bioanalysis       Date:  2014-10       Impact factor: 2.681
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.