Literature DB >> 25274604

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

Philip Timmerman1, 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.   

Abstract

Mesh：

Year:  2014        PMID： 25274604      PMCID： PMC4389736          DOI： 10.1208/s12248-014-9609-4

Source DB:  PubMed          Journal:  AAPS J        ISSN： 1550-7416            Impact factor:   4.009


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  22 in total

1.  Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Authors:  J W Findlay; W C Smith; J W Lee; G D Nordblom; I Das; B S DeSilva; M N Khan; R R Bowsher
Journal:  J Pharm Biomed Anal       Date:  2000-01       Impact factor: 3.935

2.  Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Authors:  Binodh DeSilva; Wendell Smith; Russell Weiner; Marian Kelley; JoMarie Smolec; Ben Lee; Masood Khan; Richard Tacey; Howard Hill; Abbie Celniker
Journal:  Pharm Res       Date:  2003-11       Impact factor: 4.200

3.  Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.

Authors:  Philip Timmerman; Steve Lowes; Douglas M Fast; Fabio Garofolo
Journal:  Bioanalysis       Date:  2010-04       Impact factor: 2.681

4.  International harmonization of bioanalytical guidance.

Authors:  Surendra K Bansal; Mark Arnold; Fabio Garofolo
Journal:  Bioanalysis       Date:  2010-04       Impact factor: 2.681

5.  Towards harmonized regulations for bioanalysis: moving forward!

Authors:  Peter van Amsterdam; Berthold Lausecker; Silke Luedtke; Philip Timmerman; Margarete Brudny-Kloeppel
Journal:  Bioanalysis       Date:  2010-04       Impact factor: 2.681

6.  Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.

Authors:  Peter van Amsterdam; Mark Arnold; Surendra Bansal; Douglas Fast; Fabio Garofolo; Steve Lowes; Philip Timmerman; Eric Woolf
Journal:  Bioanalysis       Date:  2010-11       Impact factor: 2.681

7.  2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

Authors:  Natasha Savoie; 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
Journal:  Bioanalysis       Date:  2010-12       Impact factor: 2.681

Review 8.  Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.

Authors:  Douglas M Fast; Marian Kelley; C T Viswanathan; Jacqueline O'Shaughnessy; S Peter King; Ajai Chaudhary; Russell Weiner; Anthony J DeStefano; Daniel Tang
Journal:  AAPS J       Date:  2009-04-21       Impact factor: 4.009

9.  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

10.  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
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