Some unnecessary or inadequate common practices in regulated LC-MS bioanalysis
Aimin Tan1, Kayode Awaiye, Fethi Trabelsi
1BioPharma Services Inc., Toronto, Ontario, Canada.
Bioanalysis
|November 22, 2014
Summary
This study challenges common practices in regulated liquid chromatography-mass spectrometry (LC-MS) bioanalysis, questioning requirements like calibration concentrations and extrapolation. It offers scientifically-backed alternatives for improved bioanalytical methods.
Area of Science:
- Bioanalysis
- Analytical Chemistry
- Mass Spectrometry
Background:
- Growing demand for scientifically justified bioanalytical practices.
- Need to critically evaluate existing regulatory requirements in bioanalysis.
- Focus on regulated liquid chromatography-mass spectrometry (LC-MS) bioanalysis.
Purpose of the Study:
- To critically assess common practices in regulated LC-MS bioanalysis.
- To provide scientific rationale for challenging established requirements.
- To propose scientifically sound alternative solutions.
Main Methods:
- Critical evaluation of existing bioanalytical practices.
- Scientific review of common requirements in LC-MS bioanalysis.
- Analysis of validation procedures for matrix effect and dilution integrity.
Main Results:
- Identified common practices in LC-MS bioanalysis that lack scientific justification.
- Demonstrated inadequacy of requirements such as minimum calibration concentrations and no extrapolation.
- Presented scientific reasoning for reconsidering standard quality control selection and batch requirements.
Conclusions:
- Several common practices in regulated LC-MS bioanalysis are unnecessary or inadequate.
- Scientific evidence supports challenging and revising established bioanalytical guidelines.
- Alternative approaches can enhance the scientific rigor of bioanalytical methods.
