Abstract :
In the development of medicinal products, bioanalytical methods are
used in clinical and non-clinical pharmacokinetic studies to evaluate the
efficacy and safety of drugs and their metabolites. Drug concentrations
determined in biological samples are used for the assessment of
characteristics such as in vivo pharmacokinetics (adsorption,
distribution, metabolism, and excretion), bioavailability,
bioequivalence, and drug-drug interaction. Bioanalytical methods,
based on a variety of physico-chemical and biological techniques such
as chromatography, immunoassay and mass spectrometry, must be
validated prior to and during use to give confidence in the results
generated. It is the process used to establish that a quantitative
analytical method is suitable for biomedical applications. Any method
developed for the analysis of analytes in biological fluids must yield
consistent results despite the variations in conditions during the course
of a project. An ideal bioanalytical method should include all of the
probable effects that are going to occur during the routine analysis of
study samples.
The present manuscript focuses on the consistent evaluation of the key
bioanalytical validation parameters is discussed accuracy, precision,
sensitivity, selectivity, limits ofquantification, range, linearity,
ruggedness, robustness, and stability. Some of the proposals were
made to the validation procedure to encounter the possible situations
in the routine study sample analysis. An attempt has been made to
understand and explain the bioanalytical method validation for
chromatographic assays from the quality assurance auditor viewpoint.
A good understanding of the background and principles of the
bioanalytical method validation will help the quality assurance
personnel to perform their duties in a most effective and focused
manner.
Keyword :
Bioanalytical method,Biomedical applications, Validation parameters, Quality assurance auditor.