Help calculate IVIVC [Dissolution / BCS / IVIVC]

posted by Pharmacist – 2007-12-20 15:06  – Posting: # 1405
Views: 5,896

(edited by Pharmacist on 2007-12-20 23:09)

Dear colleagues,
I am a beginning specialist, please help me with the following question. I cannot in any way calculate IVIVC with the aid of WinNonLin 5.2 with IVIVC wizard (I am earlier did not work with this program). I have pharmacokinetics and in vitro dissolution data for the preparation with immediate-release mechanism. Data are presented in attached file. Please describe the sequence of actions of calculation and briefly essence. How I understood for the present instance it is possible to calculate only the level C of correlation.
I do not know that to do and from what to begin.
Beforehand thankful all who will help!

P.S. Sorry of my English

Example of my data:
in vivo:
TabA (Ref)                 |TabB (Test)
Time(hr) |Concent(ng/ml)   |Time       |Concent(ng/ml)
0        |0                |0          |0
0.25     |124.076          | 0.25      |49.638
0.5      |296.299          | 0.5       |198.208
1        |269.707          | 1         |225.349
1.5      |238.699          | 1.5       |221.238
2        |205.115          | 2         |199.37
3        |151.659          | 3         |162.662
4        |107.232          | 4         |117.414
6        |68.252           | 6         |71.551
8        |50.73            | 8         |52.363
12       |31.607           | 12        |31.963
15       |26.059           | 15        |25.468
24       |10.854           | 24        |9.982
30       |3.278            | 30        |3.888
36       |0.588            | 36        |1.765


in vitro:
        TabA (Ref)      |TabB (Test)   
        Time(hr)|Fdiss_%|Time(hr)|Fdiss_%
pH 1.2
        0       |0      |0       |0
        0.08(3) |96.5   |0.08(3) |100.8
        0.167   |101.8  |0.167   |102.1
        0.25    |102.1  |0.25    |102.1
        0.417   |102.2  |0.417   |102.2
        0.58(3) |102.1  |0.58(3) |102.2
        0.75    |102    |0.75    |102.2
            
pH 4.5   
        0       |0      |0       |0
        0.08(3) |30.8   |0.08(3) |22.7
        0.167   |55.3   |0.167   |46.9
        0.25    |74.2   |0.25    |62.9
        0.417   |93.9   |0.417   |80.3
        0.58(3) |100    |0.58(3) |90
        0.75    |101.4  |0.75    |95.6
            
pH 6.8 
        0       |0      |0       |0
        0.08(3) |19.1   |0.08(3) |16.6
        0.167   |36.5   |0.167   |31.3
        0.25    |55     |0.25    |44.3
        0.417   |73.3   |0.417   |59.2
        0.58(3) |82.4   |0.58(3) |69.3
        0.75    |86.6   |0.75    |75.6

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