Exemplu 1 amlodipina Helcor-Pfizer

7.0

H 3C

H
N
O
O

H3CO

NH2

Tensicor

CH3

Norvasc

6.0
Cl

O
10

Tensicor
Norvasc

5.0
Concentration (ng/ml)

Concentration (ng/ml)

4.0

1
0

25

50

75

100

125

150

3.0
0

Time (hr)

2.0
1.0
0.0
0

25

50

75
Time (hr)

100

125

150

Exemplu1 -amlo
Cmax:

0.94 - 1.18

ASCobs: 0.99-1.12
ASCtotal: 0.99-1.13
Tmax: NS

Subiect

Cmax

Tmax

AUClast

AUCtot

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
N
Mean

4.16294
5.24494
2.44109
5.32046
5.35748
5.79598
9.69574
4.65925
6.49793
4.68359
2.47285
4.11585
6.53455
4.35355
7.52377
3.63441
3.80019
3.67747
5.29346
5.31495
4.39365
5.1025
8.27534
23

4
3
5
9
7
7
11
9
4
4
10
5
4
4
3
12
4
11
4
9
7
8
9
23

117.152
168.487
106.581
294.732
241.871
253.15
223.223
246.316
360.06
249.149
121.697
129.102
200.589
165.023
349.869
118.992
126.39
157.313
188.199
171.336
153.787
212.865
140.146
23

123.287
185.53
111.774
360.638
271.808
260.802
234.819
273.33
433.776
272.229
132.05
134.089
212.309
175.87
392.276
124.898
133.733
176.037
194.401
184.843
166.909
232.285
148.985
23

6.6522

195.48

214.64

5.1457
Harmomea
n
4.6301
GeoMean
4.8853
SEM
0.358
SD
1.7169
Median
5.1025
Min
2.4411
Max
9.6957

%AUCextr
a
4.97631
9.18626
4.64593
18.2749
11.0141
2.93384
4.93796
9.88322
16.994
8.47819
7.84048
3.71879
5.52012
6.16796
10.8104
4.72866
5.49095
10.6364
3.19063
7.30718
7.86181
8.36033
5.93295
23
7.7779

thalf
28.1263
37.9864
25.8155
56.7956
43.8956
26.1911
32.8356
40.5565
53.4473
40.9073
38.5543
24.6134
34.5755
35.7562
45.2675
28.5695
33.9736
42.7477
35.0553
42.9895
44.1975
39.0507
35.5612
23
37.716

6.2545
5.5026

173.34

186.49

35.995
6.9571

6.0522

183.74

199.41

0.60174

15.133

18.455

36.853
0.82305
1.7261
3.9472

2.8858
7

72.575

88.507

8.2783
7.3072

171.34

185.53

37.986
2.9338

106.58

111.77

12

24.613
18.275

360.06

433.78

56.796

Exemplu 2 amlodipina VIM SP-pfizer

H 3C

7.0

H
N
O
O

H3CO

Concentration (ng/ml)

6.0

Cl

NH2

Amlodipin
CH3

Norvasc

5.0
4.0
3.0
2.0
1.0
0.0
0

25

50

75
Time (hr)

100

125

150

Exemplu1 -amlo
Cmax:

0.94 - 1.18

ASCobs: 0.99-1.12
ASCtotal: 0.99-1.13
Tmax: NS

Subiect

Cmax

Tmax

AUClast

AUCtot

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
N
Mean

4.16294
5.24494
2.44109
5.32046
5.35748
5.79598
9.69574
4.65925
6.49793
4.68359
2.47285
4.11585
6.53455
4.35355
7.52377
3.63441
3.80019
3.67747
5.29346
5.31495
4.39365
5.1025
8.27534
23

4
3
5
9
7
7
11
9
4
4
10
5
4
4
3
12
4
11
4
9
7
8
9
23

117.152
168.487
106.581
294.732
241.871
253.15
223.223
246.316
360.06
249.149
121.697
129.102
200.589
165.023
349.869
118.992
126.39
157.313
188.199
171.336
153.787
212.865
140.146
23

123.287
185.53
111.774
360.638
271.808
260.802
234.819
273.33
433.776
272.229
132.05
134.089
212.309
175.87
392.276
124.898
133.733
176.037
194.401
184.843
166.909
232.285
148.985
23

6.6522

195.48

214.64

5.1457
Harmomea
n
4.6301
GeoMean
4.8853
SEM
0.358
SD
1.7169
Median
5.1025
Min
2.4411
Max
9.6957

%AUCextr
a
4.97631
9.18626
4.64593
18.2749
11.0141
2.93384
4.93796
9.88322
16.994
8.47819
7.84048
3.71879
5.52012
6.16796
10.8104
4.72866
5.49095
10.6364
3.19063
7.30718
7.86181
8.36033
5.93295
23
7.7779

thalf
28.1263
37.9864
25.8155
56.7956
43.8956
26.1911
32.8356
40.5565
53.4473
40.9073
38.5543
24.6134
34.5755
35.7562
45.2675
28.5695
33.9736
42.7477
35.0553
42.9895
44.1975
39.0507
35.5612
23
37.716

6.2545
5.5026

173.34

186.49

35.995
6.9571

6.0522

183.74

199.41

0.60174

15.133

18.455

36.853
0.82305
1.7261
3.9472

2.8858
7

72.575

88.507

8.2783
7.3072

171.34

185.53

37.986
2.9338

106.58

111.77

12

24.613
18.275

360.06

433.78

56.796

Exemplu 3 ibuprofen Terapia-BOOTS CO.

PLC. - ANGLIA
45

CH3

40
35
Concentratie (ug/ml)

COOH

CH3

Paduden
Nurofen

H3C

30
25
20
15
10
5
0
0

Timp (h)

10

12

14

Exemplu 3 ibuprofen Terapia - BOOTS

Cmax:

0.98 - 1.13

ASCobs: 0.92-1.05
ASCtotal: 0.91-1.01
Tmax: NS

Exemplu 4 ciprofloxacina (Helcor-Bayer)

HN

3500

3000

Ciprolen
F

Concentratie (ng/ml)

2500

COOH

Ciprobay

2000
1500
1000
500
0
0
-500

10

15
Timp (h)

20

25

30

Exemplu 5- atenolol (Terapia AZ)

700

Atenolol
600

Concentratie (ng/ml)

Tenormin

500

NH2

CH3

400

O
H3 C

N
H

O
OH

300
200
100
0
0

10

15

20
Timp
(h)

Exemplu 6 nizatidina (Sicomed-Eli Lilly)

2500

Nizotin
Axid

H 3C

CH3

HN

1500

CH3

S
N
H

1000

NO2

500

0
0

Timp (h)

10

12

250
14

Nizotin

200

Axid
Concentratie (ug/ml)

Concentratie (ug/ml)

2000

150

100

50

0
0
-50

8
Timp (h)

10

12

14

Exemplu 7 simvastatin (Helcor - MERCK

SHARP & DOHME
HO

12.0

Sintenal
O
H

8.0
H3 C

6.0

O
H3 C

CH3

H
CH3

4.0
H3 C

2.0
0.0

4.5

10

15

20

25

-2.0
-4.0

Sintenal

4.0
30

Zocor

3.5

Timp (h)

Concentratie (ng/ml)

Concentratie (ng/ml)

Zocor

10.0

3.0
2.5
2.0
1.5
1.0
0.5
0.0
-0.5 0
-1.0

10

15
Timp (h)

20

25

30

Exemplu 8 spironolactona (Helcor Pfizer)

70.0

Alspiron
Aldactone
O

50.0
O

H 3C

40.0
CH3

30.0

20.0

10.0

O
CH3

140.0

Alspiron
Aldactone

120.0

0.0

6
Time (hr)

12

100.0
Concentration (ng/ml)

Concentration (ng/ml)

60.0

H3C

80.0

CH3

60.0
40.0

20.0
0.0
0

25

50

-20.0
Time (hr)

75

Exemplu 9 tamoxifen (Sindan Pfizer)

30

REF

25
Concentratie (ng/ml)

30
25
Concentratie (ng/ml)

TEST

TEST

20

REF

15
10
5

20

0
-1

Timp (h)

14

19

24

15
O
N

10

H3C

CH3

CH3

5
0
0

200

400

600
Timp (h)

800

1000

1200

Exemplu 9 tamoxifen (Sindan Pfizer)

12

TEST

10
Concentratie (ng/ml)

REFERINTA
8
6
4
2
0
0

200

400

600
Timp (h)

800

1000

1200

Concentratie (ng/ml)

Exemplu 10 (Helcor- Gedeon Richter)

70

Vimpocetin

60

Cavinton

50
H
N

40

N
H3C

30

O
O

20

CH3

10
0
0

4
Timp (h)

Exemplu 11 (fenofibrat)
6000

Test -f1
Lipanthyl

5000
Concentratie (ng/ml)

O
O

Cl

4000

CH3
O

H3C

CH3

CH3

3000
O

2000
1000
0
0
-1000

20

40

60

80

Timp (h)

100

120

140

Exemplu 11 (fenofibrat)
6000

Test- F2
Lipanthyl

Concentration (ng/ml)

5000
O

4000

CH3

Cl

O
H3C

3000

CH3

CH3

2000
1000
0
0
-1000

20

40

60

80

Time (hr)

100

120

140

Exemplu 12 felodipina SR 24 ore

5000
H 3C

H
N

Experiment
Plendil

CH3

4500

Concentration (ng/ml)

H3CO

4000

O
Cl

3500

CH3

3000
Cl

2500
2000
1500
1000
500
0
0

24

48

72

96
Time (hr)

120

144

168

192

Exemplu 13 Pentoxi (Helcor Aventis)

Pentoxi:
350
Angiopent

300

H3C

CH3

Trental

Concentration (ng/ml)

250

O
200

CH3

150
100

50
0
0

24

48

72
Time (hr)

96

120

144

Exemplu 13 Pentoxi (Helcor Aventis)

M1:
Angiopent
800

Trental

700

Concentration (ng/ml)

600
500
400
300
200
100
0
0

24

48

72
Time (hr)

96

120

144

Exemplu 13 Pentoxi (Helcor Aventis)

M2:
1400

Angiopent
Trental

1200

Concentration (ng/ml)

1000
800
600
400

200
0
0

24

48

72
Time (hr)

96

120

144