Bioequivalence and Bioavailability Forum • Help calculate IVIVC

Pharmacist
●

2007-12-20 15:06
(edited by Pharmacist on 2007-12-20 23:09)

Posting: # 1405
Views: 5,639

Help calculate IVIVC [Dissolution / BCS / IVIVC]

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

Jaime_R
★★

Barcelona,
2007-12-20 20:41

@ Pharmacist
Posting: # 1407
Views: 4,471

Help calculate IVIVC

Post reply

Dear Pharmacist (what a name)!

» P.S. Sorry of my English

Don't worry, there are just a few native speakers here... ;-)


TabA (Ref)      |TabB (Test)   

Time(hr)|Fdiss_%|Time(hr)|Fdiss_%

0       |0      |0       |0

...     |...    |...     |...

0.417   |93.9   |0.417   |0.3

                          ^^^

I guess, this is a typing error?

I don't have the IVIVC Toolkit myself, but maybe you can give us a corrected number - so that others may help better.

—
Regards, Jaime

Pharmacist
●

2007-12-20 23:17
(edited by Pharmacist on 2007-12-21 09:19)

@ Jaime_R
Posting: # 1408
Views: 4,549

Help calculate IVIVC

Post reply

» Dear Pharmacist (what a name)!

Hi, my name Antoni (see in my profile)


TabA (Ref)      |TabB (Test)   

Time(hr)|Fdiss_%|Time(hr)|Fdiss_%

0       |0      |0       |0

...     |...    |...     |...

0.417   |93.9   |0.417   |0.3

                          ^^^

I guess, this
» is a typing error?
Oh, sorry this is really typing error. Already it corrected.

» I don't have the IVIVC Toolkit myself, but maybe you can give us a
» corrected number - so that others may help better.

I also hope for the aid of the specialists of this forum, since I do not know what more rightly to begin.
It is possible without the use of this Toolkit. For me the main thing to understand principle and sequence of calculate :confused:

based on a good example. It is simple in the presence only this program (WinNonLin) and M$ Excel.
Thank's for help!

Pharmacist
●

2008-01-15 01:00

@ Pharmacist
Posting: # 1517
Views: 4,558

Help calculate IVIVC

Post reply

Dear Experts,
I have re-read themes of a forum and have come to conclusion what to calculate in my case IVIVC - it is impossible. It is necessary to have necessarily referential pharmacokinetic data (Oral, IV or Infusion). I have decided to simulate these data having substituted approximate average value. On a bookmark in vitro for Internal Validation I put TabA and TabB, as model I took - model Hill's (though it incorrectly actually, I so think).
Whether correctly I do?

And one more question:
I have discovered paper: http://www.locumusa.com/pdf/members/ivivc-01.pdf
In it to be said, that exists Biopharmaceutics Drug Classification for Extended Release Drug Products. Where it is possible to read more in detail about this classification, for Extended Release Drug Products and on how many officially it can use?

Thank's for help!