Document Detail


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.
MedLine Citation:
PMID:  24961918     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.
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
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-6-25
Journal Detail:
Title:  The AAPS journal     Volume:  -     ISSN:  1550-7416     ISO Abbreviation:  AAPS J     Publication Date:  2014 Jun 
Date Detail:
Created Date:  2014-6-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101223209     Medline TA:  AAPS J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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