Data Hasil Uji BE (data urin)

SUBYEK 1
R (PEMBANDING)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 115 0 0 0,0000
8 8 4 67 90 60,3 60,3 7,5375
15 7 11,5 32 95 30,4 90,7 4,3429
23 8 19 5 105 5,25 95,95 0,6563
30 7 26,5  xxxxx  xxxxx 2,5 98,45 0,3571
35 5 32,5  xxxxx  xxxxx 0 98,45 0,0000

Ae 0-35 (mg) Ae 0-35 98,45

dAe/dt max (mg/jam) (dAe/dt)max 7,5375

T (UJI)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 110 0 0 0,0000
8 8 4 71 85 60,35 60,35 7,5438
 15 7 11,5 31 90 27,9 88,25 3,9857
23 8 19 8 100 8 96,25 1,0000
30 7 26,5  xxxxx  xxxxx 1 97,25 0,1429
35 5 32,5  xxxxx  xxxxx 1 98,25 0,2000
subyek 1 Rasio
Ae 0-35 (mg) Ae 0-35 98,25 0,997969
dAe/dt max (mg/jam) (dAe/dt)max 7,5438 1,000829

SUBYEK 2
R (PEMBANDING)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 120 0 0 0,0000
8 8 4 50 115 57,5 57,5 7,1875
15 7 11,5 29 110 31,9 89,4 4,5571
23 8 19 1 105 1,05 90,45 0,1313
30 7 26,5 xxxxx xxxxx 1,5 91,95 0,2143
35 5 32,5 xxxxx xxxxx 0 91,95 0,0000

Ae 0-35 (mg) Ae 0-35 91,95

dAe/dt max (mg/jam) (dAe/dt)max 7,1875

T (UJI)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 117 0 0 0,0000
8 8 4 54 112 60,48 60,48 7,5600
15 7 11,5 28 107 29,96 90,44 4,2800
23 8 19 2 102 2,04 92,48 0,2550
30 7 26,5 xxxxx xxxxx 0,5 92,98 0,0714
35 5 32,5 xxxxx xxxxx 0 92,98 0,0000 Subyek 2 Rasio
1,011202
 Ae 0-35 (mg) Ae 0-35 92,98 1,051826
dAe/dt max (mg/jam) (dAe/dt)max 7,5600

SUBYEK 3
R (PEMBANDING)
Cu (mg Ae Kum dDu/dt
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg)
%) (mg) (mg/jam)
0 0 0 0 107 0 0 0,0000
8 8 4 57 102 58,14 58,14 7,2675
15 7 11,5 33 97 32,01 90,15 4,5729
23 8 19 9 92 8,28 98,43 1,0350
30 7 26,5 xxxxx xxxxx 2 100,43 0,2857
35 5 32,5 xxxxx xxxxx 0 100,43 0,0000

Ae 0-35 (mg) Ae 0-35 100,43

dAe/dt max (mg/jam) (dAe/dt)max 7,2675

T (UJI)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 112 0 0 0,0000
8 8 4 52 107 55,64 55,64 6,9550
15 7 11,5 31 102 31,62 87,26 4,5171
23 8 19 10 97 9,7 96,96 1,2125
30 7 26,5 xxxxx xxxxx 2 98,96 0,2857
35 5 32,5 xxxxx xxxxx 0 98,96 0,0000
Subyek 3 Rasio
Ae 0-35 (mg) Ae 0-35 98,96 0,985363
dAe/dt max (mg/jam) (dAe/dt)max 6,9550 0,957

SUBYEK 4
R (PEMBANDING)
t (jam) Δt (jam) tmp Cu (mg Vu (ml) Ae antar t (mg) Ae Kum dAe/dt (mg/jam)
 %) (mg)
0 0 0 0 116 0 0 0,0000
8 8 4 56 111 62,16 62,16 7,7700
15 7 11,5 29 106 30,74 92,9 4,3914
23 8 19 2 101 2,02 94,92 0,2525
30 7 26,5 xxxxx xxxxx 0 94,92 0,0000
35 5 32,5 xxxxx xxxxx 0 94,92 0,0000

Ae 0-35 (mg) Ae 0-35 94,92

dAe/dt max (mg/jam) (dAe/dt)max 7,7700

T (UJI)
Cu (mg Ae Kum
t (jam) Δt (jam) tmp Vu (ml) Ae antar t (mg) dAe/dt (mg/jam)
%) (mg)
0 0 0 0 113 0 0 0,0000
8 8 4 51 108 55,08 55,08 6,8850
15 7 11,5 34 103 35,02 90,1 5,0029
23 8 19 4 98 3,92 94,02 0,4900
30 7 26,5 xxxxx xxxxx 1 95,02 0,1429
35 5 32,5 xxxxx xxxxx 0 95,02 0,0000
Subyek 4 Rasio
Ae 0-35 (mg) Ae 0-35 95,02 1,001054
dAe/dt max (mg/jam) (dAe/dt)max 6,8850 0,8861

Du 0-35 = dDu/dt
Du 0-35 = T R =T dDu/dt = R
98,25 98,45 7,54 7,54
92,98 91,95 7,56 7,19
98,96 100,43 6,96 7,27
95,02 94,92 6,89 7,77
96,3025 96,4375 7,2375 7,4425
0,99860013 99,860013 0,972455 97,24555
 Data Urin
Du 0-35 =
Subyek Du 0-35 = R dAe/dt =T dAe/dt = R
T Kesimpulan :
1 98,25 98,45 7,54 7,54 Data menunjukkan memenuhi persyaratan kriteria
2 92,98 91,95 7,56 7,19 uji bioekivalensi 1,00 dengan 90% CI = 80,00 - 125,00%
3 98,96 100,43 6,96 7,27
4 95,02 94,92 6,89 7,77
Rata-rata 96,3025 96,4375 7,2375 7,4425
0,99860013 99,86001296 0,972455492 97,24554921
Pengambilan Sampel Biologis (Darah)

C (bpj) A baku A rec (darah) C sampel (rec)(bpj) %recovery

100 0,102 0,11 111,4079 111,4079
200 0,206 0,183 182,4986 91,2493
300 0,296 0,283 279,8831 93,29436667
400 0,398 0,354 384,0262 96,00655
500 0,51 0,54 530,1614 106,03228
600 0,618 0,59 578,8536 96,4756

Sampel darah mengandung asam salisilat, A = 0.392

Regresi I = dari regresi baku Rata-rata = 99,08

C baku (bpj) vs A baku SD = 7,89
a= -0,0044 KV = 7,96
b= 0,001026857 Syarat %recovery = 80-120% (FDA)
r= 0,9994 r tabel = 0.9172
y= a + bx
y= (-4,4x10^-3) + 1,0269x10^-3x

Regresi II
C baku (bpj) vs A recovery (darah) Sampel darah, A = 0.392
a
= -0,01087 y = (-1.087x10^-2)+ (1.012x10^-3)x
b
= 0,001012 0.392 = (-1.087x10^-2)+ (1.012x10^-3)x
r = 0,9885 r tabel = 0.9172 x= ?
y = a + bx x = 398,0896
y = (-1.087x10^-2)+ (1.012x10^-3)x
Pengambilan Sampel Biologis (Urin)

C (bpj) A baku A rec (urin) C sampel (rec) (bpj) %recovery

100 0,102 0,105 106,5387 106,5387
200 0,206 0,19 189,31552 94,65776
300 0,296 0,253 250,6677 83,5559
400 0,398 0,421 414,2738 103,56845
500 0,51 0,487 421,0907 84,21814
600 0,618 0,621 609,0428 101,5071333
Sampel urin mengandung asam salisilat, A = 0.237

Regresi I = dari regresi baku Rata-rata = 95,67

C baku (bpj) vs A baku SD = 9,93
a = -0,0044 KV = 10,38
80-120%
b= 0,001026857 Syarat %recovery = (FDA)
r= 0,9994 r tabel = 0.9172
y= a + bx
y= (-4,4x10^-3) + 1,0269x10^-3x
C baku (bpj) vs A recovery (urin) Sampel urin, A = 0.237
a = -0,017733 y = (-1.772x10^-2)+(1.04x10^-3)
b = 0,0010397 0.237 =(-1.772x10^-2)+(1.04x10^-3)
r = 0,9921 r tabel = 0.9172 x= ?
y = a + bx x = 245,0032
y = (-1.772x10^-2)+(1.04x10^-3)