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Glossary

The names used for the variables of the result datasets, with their symbols and the page that defines them. Units are derived from the units of the input; value is the unit of the measured values, time the unit of the times, dose the unit of the doses.

name symbol meaning unit page
auc_last \(\mathrm{AUC}_{0\text{-}t_\mathrm{last}}\) area under the curve to the last measurable value value·time NCA
auc_all, aumc_all \(\mathrm{AUC}_\mathrm{all}\) area (and moment) to the last observation, the trailing zeros and the values a BLQ rule imputed included value·time, value·time² NCA
auc_inf_obs, auc_inf_pred \(\mathrm{AUC}_{0\text{-}\infty}\) area extrapolated to infinity, observed or predicted last value value·time NCA
auc_extrap_fraction extrapolated fraction of \(\mathrm{AUC}_{0\text{-}\infty}\) – NCA
aumc_last, aumc_inf \(\mathrm{AUMC}\) area under the first moment curve value·time² NCA
mrt \(\mathrm{MRT}\) mean residence time time NCA
thalf_eff \(t_{1/2,\mathrm{eff}}\) effective half-life, \(\ln 2 \cdot \mathrm{MRT}\) time NCA
cmax, tmax \(C_\mathrm{max}\), \(t_\mathrm{max}\) maximum and its time value, time NCA
cmin, tmin \(C_\mathrm{min}\), \(t_\mathrm{min}\) minimum and its time value, time NCA
clast, tlast \(C_\mathrm{last}\), \(t_\mathrm{last}\) last measurable (positive) value and its time value, time NCA
clast_pred \(\hat C_\mathrm{last}\) the terminal regression at \(t_\mathrm{last}\), \(e^{b - \lambda_z t_\mathrm{last}}\) value NCA
tlag \(t_\mathrm{lag}\) lag of the absorption: the last sample after the dose before the first measurable value (extravascular), 0 when the first sample at or after the dose is already measurable time NCA
c0 \(C_0\) back-extrapolated value at time 0 (bolus) value NCA
c0_method rule which produced \(C_0\): 0 none, 1 back extrapolation, 2 first value – NCA
auc_back_extrap_fraction, aumc_back_extrap_fraction share of \(\mathrm{AUC}_{0\text{-}\infty}\) (of \(\mathrm{AUMC}_{0\text{-}\infty}\)) the segment from the dose to the first sample contributes (bolus) – NCA
cmax_half, tmax_half half maximum during absorption value, time NCA
lambda_z \(\lambda_z\) terminal rate constant 1/time NCA
thalf \(t_{1/2}\) terminal half-life time NCA
lambda_z_n_points, lambda_z_t_first, lambda_z_t_last, lambda_z_r2, lambda_z_r2_adj, lambda_z_intercept, lambda_z_stderr regression diagnostics (lambda_z_t_first, lambda_z_t_last: first and last point of the terminal window; lambda_z_stderr: standard error of the slope of the terminal regression) –, time, time, –, –, –, 1/time NCA
lambda_z_span half-lives the terminal phase covers, \((t_\mathrm{last} - t_\mathrm{first}) / t_{1/2}\); below 2 the sample is flagged SPAN_LOW – NCA
cl, cl_f \(\mathrm{CL}\), \(\mathrm{CL}/F\) clearance, relative to the fraction absorbed l/h NCA
vz, vz_f \(V_z\), \(V_z/F\) terminal volume of distribution l NCA
vss \(V_\mathrm{ss}\) steady state volume of distribution l NCA
auc_inf_dn, cmax_dn dose normalized exposure and maximum value·time/dose, value/dose NCA
x_dn any parameter x per dose, from NCAResult.dose_normalized (auc_last_dn, auc_all_dn, auc_tau_dn, cavg_dn, cmax_ss_dn, c0_dn, ...) unit of x/dose NCA
dose_amount \(D\) dose amount of a sample, the coordinate of a result the dose normalized variables divide by dose NCA
lloq limit of quantification of a sample, a coordinate of a batch and of its result value NCA
auc_tau \(\mathrm{AUC}_{0\text{-}\tau}\) area over a dosing interval value·time NCA
cmin_ss, cmax_ss, ctrough, cavg \(C_\mathrm{min,ss}\), \(C_\mathrm{max,ss}\), \(C_\mathrm{trough}\), \(C_\mathrm{avg}\) minimum, maximum, trough and average over the interval value NCA
fluctuation, swing peak-trough fluctuation and swing over the interval, read against \(C_\mathrm{min,ss}\) – NCA
fluctuation_tau, swing_tau, ptr \(\mathrm{PTR}\) the same two measures read against \(C_\mathrm{trough}\), and the peak-trough ratio \(C_\mathrm{max,ss} / C_\mathrm{trough}\) – NCA
auc_tau_extrap_fraction share of \(\mathrm{AUC}_{0\text{-}\tau}\) extrapolated to complete an interval whose last sample fell short of its end (NCAOptions.tau_tolerance), 0 when the data covers the interval – NCA
accumulation_ratio \(R_\mathrm{pred}\) accumulation at steady state, predicted from \(\lambda_z\) – NCA
accumulation_ratio_obs \(R_\mathrm{obs}\) observed accumulation, last over first dosing interval of a protocol – NCA
accumulation_ratio_cmax_obs, accumulation_ratio_cmin_obs, accumulation_ratio_ctrough_obs the same ratio of the peak, the minimum and the trough of the interval – NCA
stationarity_ratio \(\mathrm{SR}\) \(\mathrm{AUC}_{0\text{-}\tau}\) at steady state over \(\mathrm{AUC}_{0\text{-}\infty}\) of the single dose (accumulation_ratio) – NCA
tss \(t_\mathrm{ss}\) time to steady state from the troughs of the dosing intervals (time_to_steady_state) time NCA
f_abs, f_rel \(F\) absolute and relative bioavailability, the dose normalized exposure of a test over a reference treatment (bioavailability) – NCA
cl_ss, cl_ss_f \(\mathrm{CL}_\mathrm{ss}\), \(\mathrm{CL}_\mathrm{ss}/F\) clearance at steady state (_f: extravascular) l/h NCA
n_doses, tau \(K\), \(\tau\) number of doses of the protocol, length of the last dosing interval –, time NCA
interval_auc, interval_cmax, interval_tmax, interval_cmin, interval_ctrough, interval_c_start, interval_cavg, interval_fluctuation, interval_swing, interval_n_points parameters of every single dosing interval, over the extra dimension interval value·time, value, time, value, value, value, value, –, –, – NCA
interval_start, interval_end, interval_dose bounds and dose amount of a dosing interval (columns of NCAResult.intervals()) time, time, dose NCA
e0, emax_obs, temax baseline, maximum effect and its time value, value, time NCA
auec_last, auec_baseline \(\mathrm{AUEC}\) area under the effect curve, raw and baseline corrected value·time NCA
emax_baseline, time_above baseline corrected maximum, time above a threshold value, time NCA
auec_tau, emin_ss, emax_ss, eavg, time_above_tau steady state effect parameters of the last dosing interval, and interval_auec, interval_emax, interval_temax, interval_emin, interval_eavg, interval_time_above per interval value·time, value, value, value, time Pharmacodynamics
accepted whether the sample meets every threshold of NCAOptions.acceptance (boolean) – NCA
excluded, excluded_reason whether the sample is left out of the summaries and the statistics, and why (NCAResult.exclude) – NCA
auc_<name> \(\mathrm{AUC}_{t_1\text{-}t_2}\) a named partial area of NCAOptions.partial_aucs, one variable per interval value·time NCA
flags NCAFlag bits, including SPAN_LOW of the terminal phase, NOT_ACCEPTED of the acceptance criteria, PARTIAL_EXTRAPOLATED of a named partial area and INCOMPLETE_INTERVAL, EXTRAPOLATED_TROUGH of a multiple dose analysis – NCA
x_sd, x_se standard deviation over subjects and standard error of the mean of a parameter x unit of x Uncertainty
x_ci_low, x_ci_high confidence interval of the estimate of a parameter x at ci_level unit of x Uncertainty
x_pi_low, x_pi_high percentile interval of individual curves of a parameter x, BootstrapSpread.SD draws only unit of x Uncertainty
x_geomean, x_geocv geometric mean and geometric coefficient of variation over subjects of a parameter x (log-normal parameters) unit of x, – Uncertainty
x_median, x_q25, x_q75, x_min, x_max, x_n median, quartiles, smallest and largest value and count of finite values of a parameter x (summary only) unit of x, unit of x, unit of x, unit of x, unit of x, – Uncertainty
x_cv \(\mathrm{CV}\) coefficient of variation of a parameter x over the samples, \(\mathrm{sd}/\lvert \bar x \rvert\), a fraction (summary only) – Uncertainty
n number of subjects (group data) or of samples along the reduced dimension (summary) – Uncertainty
auc_partial \(\mathrm{AUC}_{t_1\text{-}t_2}\) area under the curve between two times, from partial_auc value·time Uncertainty
p_se standard error of a fitted parameter p, from the Jacobian or the residual bootstrap unit of p Curve fitting
p_ci_low, p_ci_high confidence interval of a fitted parameter p at ci_level unit of p Curve fitting
p_cv relative standard error of a fitted parameter, \(\mathrm{se}(p) / \lvert p \rvert\), a fraction – Curve fitting
cost the objective of the fit at the optimum, \(\tfrac12 \sum \rho(r^2)\) – Curve fitting
r2, rmse \(R^2\), \(\mathrm{RMSE}\) goodness of fit on the unweighted residuals (rmse carries the unit of the values, it is reported as dimensionless) –, value Curve fitting
aic, aicc, bic information criteria of the fit, with \(K = k + 1\) estimated parameters – Curve fitting
n_points, n_parameters \(n\), \(k\) points used in the fit and free model parameters – Curve fitting
n_starts_converged, n_bootstrap starts which converged and converged bootstrap replicates – Curve fitting
x_data, y_data, sd_data the data of the fit, per point unit of x, unit of y, unit of y Curve fitting
y_pred, residuals prediction and weighted residual, per point unit of y, – Curve fitting
correlation correlation matrix of the fitted parameters – Curve fitting
akaike_weight \(w_i\) probability that a model is the best of the compared set – Curve fitting
bound_low, bound_high acceptance bounds of the exponent in the dose proportionality criterion – Curve fitting
gmr, log_ratio, se_log \(\mathrm{GMR}\) geometric mean ratio test / reference, its logarithm and the standard error of the logarithm – Statistics
effect, cohen_d, hedges_g \(d\), \(g\) effect of a comparison and the standardized effect sizes unit of the parameter (ratio: –), –, – Statistics
bioequivalent, p_lower, p_upper, cv_intra, p_period, p_sequence verdict and the two one-sided p values of the bioequivalence test, within-subject CV, period and carryover p values of a crossover – Statistics
kind, strength, uncertain class of an interaction (inhibitor, inducer), its strength and whether the interval spans a boundary – Statistics
estimate, variance, weight_fixed, weight_random \(\theta_i\), \(v_i\), \(w_i\) effect of a study, its variance and its normalized weights in the pooling – Statistics
q, i2, h2, tau2 \(Q\), \(I^2\), \(H^2\), \(\tau^2\) heterogeneity statistics of a meta-analysis –, %, –, – Statistics
rate, midpoint \(\dot A_k\), \(\bar t_k\) excretion rate of a urine collection and the midpoint of its interval, over the dimension collection amount/time, time Urinary excretion
max_rate, tmax_rate, rate_last, mid_pt_last \(R_\mathrm{max}\) the largest and the last measurable excretion rate with the midpoints they belong to amount/time, time, amount/time, time Urinary excretion
aurc_last, aurc_all, aurc_inf_obs, aurc_inf_pred \(\mathrm{AURC}\) areas under the excretion rate curve, which are amounts amount Urinary excretion
amount_recovered, percent_recovered, vol_ur \(A_e\), \(V_\mathrm{ur}\) the amount collected over every interval, that amount as a percentage of the dose, and the volume collected amount, %, l Urinary excretion
clr \(\mathrm{CL}_R\) renal clearance, the recovered amount over the plasma area of the collection span l/h Urinary excretion
auc_last_se, auc_last_df \(\nu\) standard error of the area of a sparse design (Bailer; Nedelman and Jia, Holder for a batch design) and its Satterthwaite degrees of freedom (Nedelman, Gibiansky and Lau) value·time, – Sparse sampling
n_animals \(n_j\) number of animals behind every nominal time of a sparse design, over the dimension time – Sparse sampling
candidate_t_first, candidate_n_points, candidate_r2_adj the candidate windows of the terminal regression over the dimension candidate: the time of the first point, the number of points and the adjusted \(R^2\) of every window the selection could choose from, kept by TerminalPhase(keep_candidates=True) for a single curve and drawn by plot_terminal_windows time, –, – Plotting
cv_intra_r, cv_intra_t \(\mathrm{CV}_{wR}\), \(\mathrm{CV}_{wT}\) within-subject CV of the reference and of the test formulation alone, from their replicates in a replicate design % Bioequivalence
scaled, limits_scaled \(\theta_L\), \(\theta_U\) whether the acceptance rule was derived from the variability of the reference or replaced by a narrow therapeutic index rule, and the derived limits – Bioequivalence
criterion \(U\) upper 95 % bound of the reference-scaled criterion of the FDA, at most zero for a bioequivalent formulation – Bioequivalence
sd_ratio_upper \((s_{wT}/s_{wR})_\mathrm{upper}\) upper 90 % bound of the ratio of the within-subject standard deviations, at most 2.500 for a narrow therapeutic index drug – Bioequivalence
anova the analysis of variance table of a replicate design: source, df, sum_sq, mean_sq, f, p_value – Bioequivalence
power, n \(1-\beta\), \(n\) power of the two one-sided tests and the total number of subjects of a design – Bioequivalence
substance the analyte of every sample, a coordinate along a sample dimension of a batch of several analytes and of its result; a batch of one names it in attrs (Timecourses.substance) – Data formats
route the route of administration of every sample, a coordinate along a sample dimension of a batch of several routes and of its result; a batch of one names it in attrs (Timecourses.route) – Data formats
nominal_time the nominal (planned) time of every observation, over the sample dimensions and time, read from the NRRLT column of an ADNCA dataset time Data formats

Statistics of the parameter tables

The columns summary_table writes, every one of them read from the summary of ParameterResult.summarize(dim) and formatted with digits significant digits as a string. stats= selects them and their order; the default is n, mean, sd, cv, geomean, geocv, median, min, max. A statistic a parameter does not carry, such as the standard deviation of a parameter read from the sampling grid, is an empty cell.

statistic variable meaning
n x_n number of samples at which the parameter is finite
mean x arithmetic mean over the samples
sd x_sd standard deviation over the samples
se x_se standard error of the mean, \(\mathrm{sd}/\sqrt{n}\)
cv x_cv coefficient of variation, a fraction in the result and a percentage in the table
geomean x_geomean geometric mean (log-normal parameters only)
geocv x_geocv geometric coefficient of variation, a percentage in the table
median, q25, q75 x_median, x_q25, x_q75 median and quartiles
min, max x_min, x_max smallest and largest value
range x_min, x_max min - max in one cell

The columns of the other tables: ratio_table writes parameter, unit, n_test, n_reference, gmr, ci_low, ci_high, ci_level and, for a bioequivalence result, cv_intra, limits and bioequivalent; ddi_table writes ratio, ci_low, ci_high, kind, strength, uncertain and source per parameter; proportionality_table writes slope, ci_low, ci_high, bound_low, bound_high, dose_low, dose_high and verdict.