Bioanalytical Method Validation

A collection of flashcards covering key vocabulary and concepts related to bioanalytical method validation.

Linearity

Assesses the correlation between analytical response and analyte concentration, indicated by calibration curves with a correlation coefficient of r² ≥ 0.98.

Precision

Measures reproducibility of measurements, expressed as coefficient of variation (%CV), which should be ≤15%.

Accuracy

Reflects how close the measured analyte concentration is to the true value, results should be within 15% of nominal values.

Robustness

Evaluates reliability of the method under small, deliberate variations in experimental conditions to confirm accuracy and precision.

Detection Limit (LOD & LOQ)

LOD is the lowest concentration detected, and LOQ is the lowest concentration accurately quantified, influenced by signal-to-noise ratios.

Validation Report

Document that ensures a bioanalytical method is scientifically sound, reproducible, and compliant with regulatory guidelines.

Selectivity vs. Specificity

Selectivity is the ability to quantify analyte in the presence of others, whereas specificity is the ability to unequivocally identify the analyte without interference.

Calibration Standards

Samples with known analyte concentrations used for generating calibration curves in analytical procedures.

Critical Reagents

Essential components in ligand-binding assays that influence accuracy, precision, and must be qualified for use.

Short-term Stability

Assesses stability of the analyte at room temperature for a time period reflective of processing delays.

Freeze-Thaw Stability

Determines the impact of repeated freezing and thawing cycles on analyte stability.

Full Validation

Complete validation of all parameters for a newly developed method to ensure its suitability.

Partial Validation

Validation performed when minor modifications are made to an already validated method.

Cross-validation

Ensures comparability and consistency of results when different methods or labs are used.

Random Sampling

All items have a chance to be selected to prevent bias in data collection.

Control Limits

Natural process limits on a control chart at ±3 SD from the mean, used to detect trends or out-of-control situations.