This difinition is also cited in Wikipedia with a small modification. This article in Wiki is a good starting point to learn on Bioanalysis.
Japan:
- Guideline on Bioanalytical Method
Validation in Pharmaceutical Development (LC, small molecule) and Q&A; (Jul.11, 2013)
@- Guideline on Bioanalytical Method (Ligand Binding Assay)
Validation in Pharmaceutical Development: (Apr.1, 2014: English translation was issued on May 30, 2014)
USA:
- Bioanalytical Method Validation [Final Guidance 05/01/01]
- Bioanalytical Method Validation [Revised Final] [Draft Guidance 09/12/13]
EU:
- Guideline on Validation of Bioanalytical Methods (EMA draft 2009)
AAPS-FDA Workshop White Paper in 2007 : Workshop/Conference Report: Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
- Mass Spectrometry and Biotechnology Resource Created and Edited by Andrew Guzzetta: Site with very links for mass spectrometry
including tutorials, freeware
- MIT OPEN COURSEWARE : Chemistry : Multiple chemistry instrumentation courses
- The Virtual Mass Spectrometry Laboratory: Virtual mass spectrometry laboratory with tutorial and excellent case
study examples. In-depth course materials for chemistry
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(Latest modification on Jul. 7, 2016.)