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RegisterIVIVC calculations [Dissolution / BCS / IVIVC]
posted by yjlee168 
– Kaohsiung, Taiwan, 2013-10-25 00:21 (4064 d 18:48 ago) – Posting: # 11760
Views: 37,648
Dear Mahendra,
If you really like to use excel, you can ask Gohel M, et. al. [quoted from their website]
The following simulated data are obtained from ivivc package.
The in-vivo (conc. obs) and in-vitro (FRD, cumulative release fraction (%)) data vs. time with two different pH (1.2 & 6.8) media are
where S: slow release; M: median release, F: fast release
These are just simulated data. You may need more subjects for in-vivo test and/or more pH and add more dosage forms with different release rates (such as "very slow", "very fast") for in-vitro test. I don't know if this is what you need or not. Please consult with official guidelines/guidance for more details in study design of ivivc. That's very mandatory. The information here is very, very brief! If you have budget, you can also consider the commercial computer program- IVIVC TOOLKIT from CERTARA (used to be Pharsight?).
If you really like to use excel, you can ask Gohel M, et. al. [quoted from their website]
... A copy of EXCEL worksheet can be obtained from the authors upon request... The following simulated data are obtained from ivivc package.
pk original data (dose = 100)for estimate 'kel' (as well as 'ka' and 'Vd') are
subj time conc
1 0.0 0.00000
1 0.5 0.35389
1 1.0 0.29890
1 1.5 0.27296
1 2.0 0.20250
1 3.0 0.09352
1 4.0 0.07649
1 5.0 0.05756
1 6.0 0.04223
1 8.0 0.03120
1 10.0 0.01482
2 0.0 0.00000
2 0.5 0.33420
2 1.0 0.26397
2 1.5 0.16668
2 2.0 0.15359
2 3.0 0.07647
2 4.0 0.04367
2 5.0 0.01475
2 6.0 0.01742
2 8.0 0.00996
2 10.0 0.00389
3 0.0 0.00000
3 0.5 0.35389
3 1.0 0.23890
3 1.5 0.14296
3 2.0 0.12504
3 3.0 0.06052
3 4.0 0.03649
3 5.0 0.00756
3 6.0 0.00223
ps. this dataset is obtained from solution or suspension dosage form.The in-vivo (conc. obs) and in-vitro (FRD, cumulative release fraction (%)) data vs. time with two different pH (1.2 & 6.8) media are
pH formula subject time conc.obs FRD
1.2 S 1 0.0 0.00000 0.00
1.2 S 1 0.5 0.02265 17.17
1.2 S 1 1.0 0.03262 19.63
1.2 S 1 1.5 0.05025 24.81
1.2 S 1 2.0 0.05025 30.38
1.2 S 1 3.0 0.13061 35.01
1.2 S 1 4.0 0.12923 40.60
1.2 S 1 5.0 0.12883 47.86
1.2 S 1 6.0 0.07619 54.07
1.2 S 1 8.0 0.04683 64.59
1.2 S 1 10.0 0.02390 72.49
1.2 S 1 12.0 0.02043 78.66
1.2 S 1 24.0 0.01746 98.05
1.2 S 2 0.0 0.00000 0.00
1.2 S 2 0.5 0.22248 13.23
1.2 S 2 1.0 0.24437 20.08
1.2 S 2 1.5 0.24437 26.41
1.2 S 2 2.0 0.27090 33.15
1.2 S 2 3.0 0.13900 40.52
1.2 S 2 4.0 0.13900 46.08
1.2 S 2 5.0 0.08430 55.70
1.2 S 2 6.0 0.06942 59.05
1.2 S 2 8.0 0.06991 69.74
1.2 S 2 10.0 0.07202 77.60
1.2 S 2 12.0 0.07862 84.47
1.2 S 2 24.0 0.02330 101.38
1.2 S 3 0.0 0.00000 0.00
1.2 S 3 0.5 0.05093 13.46
1.2 S 3 1.0 0.06240 21.23
1.2 S 3 1.5 0.11309 27.78
1.2 S 3 2.0 0.07568 34.41
1.2 S 3 3.0 0.15707 42.03
1.2 S 3 4.0 0.10396 47.58
1.2 S 3 5.0 0.06907 55.07
1.2 S 3 6.0 0.04574 62.72
1.2 S 3 8.0 0.04443 73.18
1.2 S 3 10.0 0.03608 80.52
1.2 S 3 12.0 0.01893 86.65
1.2 S 3 24.0 0.01353 101.65
1.2 M 1 0.0 0.00000 0.00
1.2 M 1 0.5 0.10740 16.70
1.2 M 1 1.0 0.15168 21.24
1.2 M 1 1.5 0.18293 27.10
1.2 M 1 2.0 0.21175 35.42
1.2 M 1 3.0 0.14171 41.53
1.2 M 1 4.0 0.13102 49.33
1.2 M 1 5.0 0.14073 56.06
1.2 M 1 6.0 0.14073 53.36
1.2 M 1 8.0 0.08957 71.22
1.2 M 1 10.0 0.05584 80.03
1.2 M 1 12.0 0.07919 84.48
1.2 M 1 24.0 0.01353 100.22
1.2 M 2 0.0 0.00000 0.00
1.2 M 2 0.5 0.12390 14.16
1.2 M 2 1.0 0.16241 21.23
1.2 M 2 1.5 0.12500 27.10
1.2 M 2 2.0 0.12500 34.91
1.2 M 2 3.0 0.14800 42.53
1.2 M 2 4.0 0.16100 48.83
1.2 M 2 5.0 0.12800 55.81
1.2 M 2 6.0 0.13200 61.00
1.2 M 2 8.0 0.12800 71.47
1.2 M 2 10.0 0.08904 78.58
1.2 M 2 12.0 0.02400 84.25
1.2 M 2 24.0 0.01710 99.54
1.2 M 3 0.0 0.00000 0.00
1.2 M 3 0.5 0.12700 13.69
1.2 M 3 1.0 0.14000 21.00
1.2 M 3 1.5 0.10400 26.41
1.2 M 3 2.0 0.10300 34.91
1.2 M 3 3.0 0.16631 43.53
1.2 M 3 4.0 0.16351 49.08
1.2 M 3 5.0 0.16351 55.07
1.2 M 3 6.0 0.11862 60.75
1.2 M 3 8.0 0.12589 69.03
1.2 M 3 10.0 0.06181 76.16
1.2 M 3 12.0 0.03234 81.84
1.2 M 3 24.0 0.01901 97.20
1.2 F 1 0.0 0.00000 0.00
1.2 F 1 0.5 0.11026 11.14
1.2 F 1 1.0 0.11617 13.86
1.2 F 1 1.5 0.13020 18.84
1.2 F 1 2.0 0.14577 19.79
1.2 F 1 3.0 0.12375 25.97
1.2 F 1 4.0 0.12305 32.09
1.2 F 1 5.0 0.08235 37.16
1.2 F 1 6.0 0.04862 41.44
1.2 F 1 8.0 0.02651 50.12
1.2 F 1 10.0 0.00304 54.28
1.2 F 1 12.0 0.00287 59.81
1.2 F 1 24.0 0.00274 84.53
1.2 F 2 0.0 0.00000 0.00
1.2 F 2 0.5 0.12571 9.75
1.2 F 2 1.0 0.08260 13.63
1.2 F 2 1.5 0.15150 18.38
1.2 F 2 2.0 0.07328 23.56
1.2 F 2 3.0 0.05693 27.72
1.2 F 2 4.0 0.06357 34.83
1.2 F 2 5.0 0.04843 39.39
1.2 F 2 6.0 0.08606 43.66
1.2 F 2 8.0 0.07116 52.33
1.2 F 2 10.0 0.04743 57.43
1.2 F 2 12.0 0.02257 62.70
1.2 F 2 24.0 0.00882 85.53
1.2 F 3 0.0 0.00000 0.00
1.2 F 3 0.5 0.16745 9.75
1.2 F 3 1.0 0.12430 13.86
1.2 F 3 1.5 0.13227 17.92
1.2 F 3 2.0 0.11946 21.55
1.2 F 3 3.0 0.06243 26.47
1.2 F 3 4.0 0.04864 32.59
1.2 F 3 5.0 0.06557 36.91
1.2 F 3 6.0 0.05926 40.94
1.2 F 3 8.0 0.04277 49.63
1.2 F 3 10.0 0.03909 53.07
1.2 F 3 12.0 0.02206 58.84
1.2 F 3 24.0 0.01088 81.53
6.8 S 1 0.0 0.00000 0.00
6.8 S 1 0.5 0.02265 13.46
6.8 S 1 1.0 0.03262 19.60
6.8 S 1 1.5 0.05025 24.80
6.8 S 1 2.0 0.05025 30.63
6.8 S 1 3.0 0.13061 36.51
6.8 S 1 4.0 0.12923 42.59
6.8 S 1 5.0 0.12883 49.35
6.8 S 1 6.0 0.07619 56.04
6.8 S 1 8.0 0.04683 66.31
6.8 S 1 10.0 0.02390 74.42
6.8 S 1 12.0 0.02043 81.06
6.8 S 1 24.0 0.01746 99.69
6.8 S 2 0.0 0.00000 0.00
6.8 S 2 0.5 0.22248 14.62
6.8 S 2 1.0 0.24437 21.70
6.8 S 2 1.5 0.24437 28.70
6.8 S 2 2.0 0.27090 35.42
6.8 S 2 3.0 0.13900 43.79
6.8 S 2 4.0 0.13900 48.09
6.8 S 2 5.0 0.08430 54.83
6.8 S 2 6.0 0.06942 61.00
6.8 S 2 8.0 0.06991 70.98
6.8 S 2 10.0 0.07202 78.83
6.8 S 2 12.0 0.07862 84.73
6.8 S 2 24.0 0.02330 100.91
6.8 S 3 0.0 0.00000 0.00
6.8 S 3 0.5 0.05093 11.14
6.8 S 3 1.0 0.06240 17.32
6.8 S 3 1.5 0.11309 22.51
6.8 S 3 2.0 0.07568 28.10
6.8 S 3 3.0 0.15707 35.50
6.8 S 3 4.0 0.10396 39.09
6.8 S 3 5.0 0.06907 45.12
6.8 S 3 6.0 0.04574 52.33
6.8 S 3 8.0 0.04443 59.94
6.8 S 3 10.0 0.03608 67.63
6.8 S 3 12.0 0.01893 73.82
6.8 S 3 24.0 0.01353 91.71
6.8 M 1 0.0 0.00000 0.00
6.8 M 1 0.5 0.10740 16.94
6.8 M 1 1.0 0.15168 22.85
6.8 M 1 1.5 0.18293 27.10
6.8 M 1 2.0 0.21175 35.17
6.8 M 1 3.0 0.14171 41.03
6.8 M 1 4.0 0.13102 48.59
6.8 M 1 5.0 0.14073 56.06
6.8 M 1 6.0 0.14073 60.76
6.8 M 1 8.0 0.08957 69.28
6.8 M 1 10.0 0.05584 77.14
6.8 M 1 12.0 0.07919 83.04
6.8 M 1 24.0 0.01353 98.36
6.8 M 2 0.0 0.00000 0.00
6.8 M 2 0.5 0.12390 15.55
6.8 M 2 1.0 0.16241 21.93
6.8 M 2 1.5 0.12500 21.83
6.8 M 2 2.0 0.12500 36.17
6.8 M 2 3.0 0.14800 44.53
6.8 M 2 4.0 0.16100 49.08
6.8 M 2 5.0 0.12800 55.32
6.8 M 2 6.0 0.13200 61.49
6.8 M 2 8.0 0.12800 69.52
6.8 M 2 10.0 0.08904 76.65
6.8 M 2 12.0 0.02400 83.04
6.8 M 2 24.0 0.01710 98.83
6.8 M 3 0.0 0.00000 0.00
6.8 M 3 0.5 0.12700 13.69
6.8 M 3 1.0 0.14000 20.31
6.8 M 3 1.5 0.10400 25.95
6.8 M 3 2.0 0.10300 33.65
6.8 M 3 3.0 0.16631 42.03
6.8 M 3 4.0 0.16351 46.83
6.8 M 3 5.0 0.16351 52.83
6.8 M 3 6.0 0.11862 58.28
6.8 M 3 8.0 0.12589 67.79
6.8 M 3 10.0 0.06181 76.63
6.8 M 3 12.0 0.03234 83.02
6.8 M 3 24.0 0.01901 98.12
6.8 F 1 0.0 0.00000 0.00
6.8 F 1 0.5 0.11026 8.83
6.8 F 1 1.0 0.11617 14.09
6.8 F 1 1.5 0.13020 17.69
6.8 F 1 2.0 0.14577 20.79
6.8 F 1 3.0 0.12375 25.71
6.8 F 1 4.0 0.12305 31.34
6.8 F 1 5.0 0.08235 35.67
6.8 F 1 6.0 0.04862 40.20
6.8 F 1 8.0 0.02651 48.40
6.8 F 1 10.0 0.00304 55.72
6.8 F 1 12.0 0.00287 61.48
6.8 F 1 24.0 0.00274 81.08
6.8 F 2 0.0 0.00000 0.00
6.8 F 2 0.5 0.12571 9.06
6.8 F 2 1.0 0.08260 14.32
6.8 F 2 1.5 0.15150 18.38
6.8 F 2 2.0 0.07328 21.55
6.8 F 2 3.0 0.05693 26.97
6.8 F 2 4.0 0.06357 33.33
6.8 F 2 5.0 0.04843 38.15
6.8 F 2 6.0 0.08606 43.41
6.8 F 2 8.0 0.07116 51.59
6.8 F 2 10.0 0.04743 57.91
6.8 F 2 12.0 0.02257 63.42
6.8 F 2 24.0 0.00882 82.51
6.8 F 3 0.0 0.00000 0.00
6.8 F 3 0.5 0.16745 9.99
6.8 F 3 1.0 0.12430 13.40
6.8 F 3 1.5 0.13227 17.23
6.8 F 3 2.0 0.11946 18.78
6.8 F 3 3.0 0.06243 24.46
6.8 F 3 4.0 0.04864 30.34
6.8 F 3 5.0 0.06557 34.92
6.8 F 3 6.0 0.05926 38.96
6.8 F 3 8.0 0.04277 47.42
6.8 F 3 10.0 0.03909 54.98
6.8 F 3 12.0 0.02206 60.51
6.8 F 3 24.0 0.01088 81.53
ps. with the same dose of 100 here.where S: slow release; M: median release, F: fast release
These are just simulated data. You may need more subjects for in-vivo test and/or more pH and add more dosage forms with different release rates (such as "very slow", "very fast") for in-vitro test. I don't know if this is what you need or not. Please consult with official guidelines/guidance for more details in study design of ivivc. That's very mandatory. The information here is very, very brief! If you have budget, you can also consider the commercial computer program- IVIVC TOOLKIT from CERTARA (used to be Pharsight?).
❝ Could you plz develop an example with hypothetical data for invivo and invitro for an IR, MR formulation and analysis in excel.
—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here
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Ing. Helmut Schütz