Bioanalytical method validation: a risk-based approach?

This publication has 25 references indexed in Scilit:

• Quantitative high‐throughput analysis of drugs in biological matrices by mass spectrometry
  Mass Spectrometry Reviews, 2003
• Quantitative characterization of differential ion suppression on liquid chromatography/atmospheric pressure ionization mass spectrometric bioanalytical methods
  Rapid Communications in Mass Spectrometry, 2002
• A strategy for a post‐method‐validation use of incurred biological samples for establishing the acceptability of a liquid chromatography/tandem mass‐spectrometric method for quantitation of drugs in biological samples
  Rapid Communications in Mass Spectrometry, 2002
• Implications of matrix effects in ultra‐fast gradient or fast isocratic liquid chromatography with mass spectrometry in drug discovery
  Rapid Communications in Mass Spectrometry, 2001
• Quantitative screening and matrix effect studies of drug discovery compounds in monkey plasma using fast‐gradient liquid chromatography/tandem mass spectrometry
  Rapid Communications in Mass Spectrometry, 2001
• Fragmentation of N‐oxides (deoxygenation) in atmospheric pressure ionization: Investigation of the activation process
  Rapid Communications in Mass Spectrometry, 2001
• Ultra‐fast gradient vs. fast isocratic chromatography in bioanalytical quantification by liquid chromatography/tandem mass spectrometry
  Rapid Communications in Mass Spectrometry, 2001
• The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory
  Analytica Chimica Acta, 1999
• A strategy for validation of bioanalytical methods
  Journal of Pharmaceutical and Biomedical Analysis, 1996
• Inspection by variables as an acceptance criterion in bioanalysis — a proposal
  Journal of Pharmaceutical and Biomedical Analysis, 1995