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Anu ★ India, 2013-07-26 14:33 (4708 d 15:50 ago) Posting: # 11063 Views: 7,064 |
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Hi All, Greetings! Kindly correct me if anyone of the following steps of mine are not correct. I am doing my first project on IVIVC by using WinNonlin IVIVC Tool-kit: Data:
Procedure:
Result: 1. After running the software got the following results for: PH-4.5 Form Parameter Predicted Observed % PE RatioSince %PE for AUC_last is <10% and not for Cmax. Does that mean IVIVC is not established? Thanks & Regards Anu Jaswal Edit: Subject line changed, lists and table BBCoded. [Helmut] |
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jag009 ★★★ NJ, 2013-07-26 17:31 (4708 d 12:52 ago) @ Anu Posting: # 11064 Views: 5,899 |
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Hi, ❝ Since %PE for AUC_last is <10% and not for Cmax. ❝ Does that mean IVIVC is not established? Correct. Additional comments:
Hope this helps. John |
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Anu ★ India, 2013-07-29 14:21 (4705 d 16:02 ago) @ jag009 Posting: # 11102 Views: 5,926 |
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Hi John, Thankyou very much for your additional comments. ❝ Additional comments: ❝ 1. An IVIVC should have 3 formulations (it takes 3 pts to do a correlation, 3=fast, target (medium), slow formulations). You only have 2. Though I have checked the Industrial Guidance for IVIVC as well IVIVC Guidance On page no 6. It is written: "Although an IVIVC can be defined with a minimum of two formulations with different release rates, three or more formulations with different release rates are recommended." So kindly guide me how can I go about it? My formulation is an Extended Release not IR. ❝ 2. Is your formulation an IR? If so, it maybe difficult to achieve IVIVC. Thanks & Regards Anu Jaswal |
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jag009 ★★★ NJ, 2013-07-30 18:13 (4704 d 12:10 ago) @ Anu Posting: # 11126 Views: 5,789 |
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Hi, Before I proceed, just want to make sure we are on the right path. 1) Where did you get the IV or IR data to generate the impulse function for convolution/deconvolution? Was the data originated from the same 2 studies or from another source? I recall some member here (forgot his name) said that's a no no and you should use the IV data from the same study subjects. Well your results showed that internal validation was a failure due to the poor predictability of the model so you don't have an IVIVC. You can generate a 2 formulation IVIVC but it will be of limited use when compared to a 3 formulation IVIVC. Particularly if you want to use it for setting dissolution specification. You can't propse +/- range for your in-vitro release spec because you can't justify or support your proposal for the +ve range if your IVIVC only shows correlation to support the -ve range of the spec, or vice versa. John |
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Anu ★ India, 2013-08-02 10:33 (4701 d 19:50 ago) @ jag009 Posting: # 11162 Views: 5,763 |
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Hi John, ❝ 1) Where did you get the IV or IR data to generate the impulse function for convolution/deconvolution? Was the data originated from the same 2 studies or from another source? ❝ Well your results showed that internal validation was a failure due to the poor predictability of the model so you don't have an IVIVC. Can I upload my data, will you please take a look upon it? ❝ You can generate a 2 formulation IVIVC but it will be of limited use when compared to a 3 formulation IVIVC. Particularly if you want to use it for setting dissolution specification. You can't propse +/- range for your in-vitro release spec because you can't justify or support your proposal for the +ve range if your IVIVC only shows correlation to support the -ve range of the spec, or vice versa. Thank you very much for this clarification. Thanks & Regards Anu Jaswal |
Ing. Helmut Schütz