Literature DB >> 21083261

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

Philip Timmerman, Steve Lowes, Douglas M Fast, Fabio Garofolo.   

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Year:  2010        PMID： 21083261     DOI： 10.4155/bio.10.34

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


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  3 in total

1.  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

2.  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

3.  AAPS Workshop Report on ICH M10.

Authors:  Brian Booth; Faye Vazvaei; Eric Fluhler; Heather Myler; Eric Woolf
Journal:  AAPS J       Date:  2019-12-10       Impact factor: 4.009
  3 in total

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