Factory functions that return commonly-used criteria sets for analytical validation workflows.
Usage
criteria_bioanalytical(
cv_qc = 15,
cv_calibration = 20,
r_squared = 0.99,
recovery_range = c(80, 120),
accuracy_bias = 15
)
criteria_ich_q2(
cv_repeatability = 2,
cv_intermediate = 5,
recovery_range = c(98, 102),
r_squared = 0.999
)
criteria_bland_altman(
loa_width = NULL,
bias_max = NULL,
proportional_bias_p = 0.05
)
criteria_method_comparison(
slope_range = c(0.9, 1.1),
intercept_range = NULL,
r_squared = 0.95
)
criteria_proficiency_testing(max_z_score = 2, pct_satisfactory = 100)
criteria_matrix_effects(me_range = c(80, 120), me_cv = 15)
criteria_surrogate_recovery(surrogate_recovery = c(70, 130))Arguments
- cv_qc
Maximum allowable CV for QC samples (default 15%, bioanalytical).
- cv_calibration
Maximum allowable CV for calibration replicates (default 20%).
- r_squared
Minimum R-squared for calibration curve.
- recovery_range
Acceptable recovery range as c(lower, upper).
- accuracy_bias
Maximum allowable bias (default 15%).
- cv_repeatability
Maximum allowable CV for repeatability (default 2%, ICH Q2).
- cv_intermediate
Maximum allowable CV for intermediate precision (default 5%, ICH Q2).
- loa_width
Maximum acceptable limits of agreement width.
- bias_max
Maximum acceptable mean bias.
- proportional_bias_p
Significance level for proportional bias test.
- slope_range
Acceptable range for regression slope (default c(0.9, 1.1)).
- intercept_range
Acceptable range for regression intercept.
- max_z_score
Maximum acceptable absolute z-score.
- pct_satisfactory
Minimum percentage of satisfactory results.
- me_range
Acceptable matrix effect range (default c(80, 120)).
- me_cv
Maximum acceptable CV of matrix effects.
- surrogate_recovery
Acceptable surrogate recovery range.
Value
A measure_criteria object.
Examples
# Default bioanalytical criteria
criteria_bioanalytical()
#> <measure_criteria> with 5 criteria
#> • QC CV <= 15%
#> • Calibration CV <= 20%
#> • R² >= 0.99
#> • Recovery 80-120%
#> • Bias within +/-15%
# Custom thresholds
criteria_bioanalytical(cv_qc = 20, r_squared = 0.98)
#> <measure_criteria> with 5 criteria
#> • QC CV <= 20%
#> • Calibration CV <= 20%
#> • R² >= 0.98
#> • Recovery 80-120%
#> • Bias within +/-15%