Literature DB >> 21942519

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Fabio Garofolo1, Mario L Rocci, Isabelle Dumont, Suzanne Martinez, Steve Lowes, Eric Woolf, Peter van Amsterdam, Surendra Bansal, Ariadna Cristina Gomes Barra, Ronald Bauer, Brian P Booth, Montserrat Carrasco-Triguero, Binodh DeSilva, John Dunn, Keith Gallicano, Dominique Gouty, Stacy Ho, Richard Hucker, Mohammed Jemal, Noriko Katori, Olivier Le Blaye, Jean Lee, Wenkui Li, Steve Michael, Corey Nehls, Robert Nicholson, Eric Ormsby, Daniel Tang, C T Viswanathan, Russell Weiner, Graeme Young.   

Abstract

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

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Year:  2011        PMID: 21942519     DOI: 10.4155/bio.11.192

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


  4 in total

1.  Large molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.

Authors:  Lauren Stevenson; Marian Kelley; Boris Gorovits; Clare Kingsley; Heather Myler; Karolina Osterlund; Arumugam Muruganandam; Yoshiyuki Minamide; Mario Dominguez
Journal:  AAPS J       Date:  2013-11-16       Impact factor: 4.009

2.  Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples.

Authors:  Eliza N Fung; Anne-Françoise Aubry; Alban Allentoff; Qin C Ji
Journal:  AAPS J       Date:  2015-05-15       Impact factor: 4.009

3.  Small molecule specific run acceptance, specific assay operation, and chromatographic run quality assessment: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization teams.

Authors:  Eric J Woolf; Stuart McDougall; Douglas M Fast; Maristela Andraus; Matthew Barfield; Michael Blackburn; Ben Gordon; David Hoffman; Noriko Inoue; Gabriel Marcelin-Jimenez; Amy Flynn; Richard LeLacheur; Scott Reuschel; Ravisankar Santhanam; Patrick Bennett; Barbara Duncan; Roger Hayes; Berthold Lausecker; Abhishek Sharma; Kazutaka Togashi; Ravi Kumar Trivedi; Miguel Vago; Stephen White; Hollie Barton; John A Dunn; Raymond H Farmen; Katja Heinig; Christopher Holliman; Junji Komaba; Maria Francesca Riccio; Elizabeth Thomas
Journal:  AAPS J       Date:  2014-06-25       Impact factor: 4.009

4.  Stability of Drugs, Drug Candidates, and Metabolites in Blood and Plasma.

Authors:  Gregory A Reed
Journal:  Curr Protoc Pharmacol       Date:  2016-12-13
  4 in total

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