New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR

What are the challenges of stability investigations and sample stabilization in regulated bioanalysis?

(2013) Katja Heinig et al.   Bioanalysis

The European Bioanalysis Forum community’s evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation

(2013) Peter van Amsterdam et al.   Bioanalysis

Confirmation of no impact from different anticoagulant counter ions on bioanalytical method

(2012) Annik Bergeron et al.   Bioanalysis

Anticoagulant counter ion impact on bioanalytical LC–MS/MS assays: results from discussions and experiments within the European Bioanalysis Forum

(2011) Carl Johan Sennbro et al.   Bioanalysis

Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis

(2011) Achim Freisleben et al.   Bioanalysis

Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum

(2010) Philip Timmerman et al.   Bioanalysis

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

(2009) Douglas M. Fast et al.   AAPS Journal