Literature DB >> 23046264

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Binodh DeSilva1, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, France Landry, Catherine Dicaire, Gabriella Szekely-Klepser, Russell Weiner, Mark Arnold, Surendra Bansal, Kevin Bateman, Ronald Bauer, Brian Booth, Scott Davis, Sherri Dudal, Dominique Gouty, John Grundy, Sam Haidar, Roger Hayes, Mohammed Jemal, Surinder Kaur, Marian Kelley, Magnus Knutsson, Olivier Le Blaye, Jean Lee, Steve Lowes, Mark Ma, Toshinari Mitsuoka, João Tavares Neto, Robert Nicholson, Eric Ormsby, Jeffrey Sailstad, Lauren Stevenson, Daniel Tang, Jan Welink, C T Viswanathan, Laixin Wang, Eric Woolf, Eric Yang.   

Abstract

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.

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Year:  2012        PMID: 23046264     DOI: 10.4155/bio.12.205

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


  8 in total

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Authors:  Marian Kelley; Christopher Beaver; Lauren F Stevenson; Ross Bamford; Paula Gegwich; Yamamoto Katsuhiko; Dongbei Li; Samantha Little; Arumugam Muruganandam; Daniela Stoellner; Ravi Kumar Trivedi
Journal:  AAPS J       Date:  2014-01-07       Impact factor: 4.009

2.  Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation.

Authors:  John F Marcelletti; Cindy L Evans; Manju Saxena; Adriana E Lopez
Journal:  AAPS J       Date:  2015-04-23       Impact factor: 4.009

3.  Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.

Authors:  R J Briggs; R Nicholson; F Vazvaei; J Busch; M Mabuchi; K S Mahesh; M Brudny-Kloeppel; N Weng; P A R Galvinas; P Duchene; Pei Hu; R W Abbott
Journal:  AAPS J       Date:  2014-09-05       Impact factor: 4.009

4.  Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform.

Authors:  Tracey H Clark; Phillip D Yates; Allison Given Chunyk; Alison P Joyce; Aidong Wu; Petar Pop-Damkov; Yiqun Zhang; Elizabeth A Dreher; Laurie A Tylaska; Jo-Ann A Wentland; Kathleen B Pelletier; Lindsay E King; Chad A Ray
Journal:  AAPS J       Date:  2016-07-11       Impact factor: 4.009

5.  From lost in translation to paradise found: enabling protein biomarker method transfer by mass spectrometry.

Authors:  Russell P Grant; Andrew N Hoofnagle
Journal:  Clin Chem       Date:  2014-05-08       Impact factor: 8.327

6.  Targeted peptide measurements in biology and medicine: best practices for mass spectrometry-based assay development using a fit-for-purpose approach.

Authors:  Steven A Carr; Susan E Abbatiello; Bradley L Ackermann; Christoph Borchers; Bruno Domon; Eric W Deutsch; Russell P Grant; Andrew N Hoofnagle; Ruth Hüttenhain; John M Koomen; Daniel C Liebler; Tao Liu; Brendan MacLean; D R Mani; Elizabeth Mansfield; Hendrik Neubert; Amanda G Paulovich; Lukas Reiter; Olga Vitek; Ruedi Aebersold; Leigh Anderson; Robert Bethem; Josip Blonder; Emily Boja; Julianne Botelho; Michael Boyne; Ralph A Bradshaw; Alma L Burlingame; Daniel Chan; Hasmik Keshishian; Eric Kuhn; Christopher Kinsinger; Jerry S H Lee; Sang-Won Lee; Robert Moritz; Juan Oses-Prieto; Nader Rifai; James Ritchie; Henry Rodriguez; Pothur R Srinivas; R Reid Townsend; Jennifer Van Eyk; Gordon Whiteley; Arun Wiita; Susan Weintraub
Journal:  Mol Cell Proteomics       Date:  2014-01-17       Impact factor: 5.911

7.  Insights on antioxidant assays for biological samples based on the reduction of copper complexes-the importance of analytical conditions.

Authors:  Sara S Marques; Luís M Magalhães; Ildikó V Tóth; Marcela A Segundo
Journal:  Int J Mol Sci       Date:  2014-06-25       Impact factor: 5.923

8.  Validation of a Commercially Available Enzyme ImmunoAssay for the Determination of Oxytocin in Plasma Samples from Seven Domestic Animal Species.

Authors:  Cecile Bienboire-Frosini; Camille Chabaud; Alessandro Cozzi; Elisa Codecasa; Patrick Pageat
Journal:  Front Neurosci       Date:  2017-09-21       Impact factor: 4.677

  8 in total

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