Stage 4: analysis (executed output)

Table 14.4.4.1 PK parameters

Executed: rtables 0.6.17 / tern 0.9.13

Synthetic data only: simulated for this worked example; not real trial data and not a regulatory deliverable.

Table 14.4.4.1 Summary of Plasma SIMDRUG PK Parameters

PK parameter set

Study SIMBE01 (synthetic)


	Test	Reference
	(N=39)	(N=39)
Maximum concentration (Cmax) (ng/mL)
n	39	39
Mean (SD)	108.8 (39.4)	107.6 (39.7)
CV%	36.3	36.9
Geometric mean	102.4	101.2
Geometric CV%	36.1	36.2
Median	94.1	101.0
Min - Max	49.2 - 211.0	46.4 - 217.0
AUC to last quantifiable conc, AUC(0-t) (h*ng/mL)
n	39	39
Mean (SD)	1261.7 (405.1)	1234.0 (414.9)
CV%	32.1	33.6
Geometric mean	1199.1	1172.4
Geometric CV%	33.5	33.2
Median	1188.4	1156.7
Min - Max	653.6 - 2111.8	609.0 - 2774.5
AUC to infinity, AUC(0-inf) (h*ng/mL)
n	38	38
Mean (SD)	1313.7 (457.7)	1268.1 (437.7)
CV%	34.8	34.5
Geometric mean	1238.7	1200.8
Geometric CV%	36.0	34.4
Median	1205.2	1177.5
Min - Max	662.0 - 2319.5	617.0 - 2838.2
AUC(0-inf) extrapolated (%)
n	39	39
Mean (SD)	4.50 (5.57)	4.15 (5.55)
CV%	123.8	133.9
Geometric mean	2.48	2.23
Geometric CV%	154.2	164.6
Median	2.35	2.07
Min - Max	0.39 - 25.85	0.23 - 30.82
Terminal half-life, t1/2 (h)
n	39	39
Mean (SD)	9.37 (4.83)	8.95 (4.91)
CV%	51.5	54.9
Geometric mean	8.28	7.85
Geometric CV%	54.5	56.1
Median	8.84	8.28
Min - Max	2.92 - 25.28	2.73 - 29.03
Terminal rate constant, lambda z (1/h)
n	39	39
Mean (SD)	0.0951 (0.0509)	0.1010 (0.0557)
CV%	53.5	55.1
Geometric mean	0.0837	0.0883
Geometric CV%	54.5	56.1
Median	0.0784	0.0837
Min - Max	0.0274 - 0.2378	0.0239 - 0.2535
Time of Cmax, tmax (h)
n	39	39
Median	1.05	1.03
Min - Max	0.25 - 4.17	0.27 - 2.05

NCA with PKNCA 0.12.1 on actual sampling times; AUC by linear-up/log-down; BLQ = 0 and omitted from lambda z (ICH M13A).

Geometric mean = exp(mean(log x)); geometric CV% = 100*sqrt(exp(s^2) - 1) on the log scale.

Periods excluded under the SAP rules are not summarized (ADPP.ANL01FL).

AUC(0-inf) is not summarized when more than 20% is extrapolated (2 profiles); lambda z-based parameters are not summarized when the adjusted R-squared is below 0.90 (0 profiles). Values kept in ADPP (NCAEXRSN).

Synthetic data; not a regulatory deliverable.

Files: t_14_4_4_1.rtf (RTF from formatters::export_as_rtf()), t_14_4_4_1.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.