Amira
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Egypt,
2014-12-10 16:30
(3396 d 04:22 ago)

Posting: # 14045
Views: 6,399
 

 What if F2 is ok but F1 isn't ? [Dissolution / BCS / IVIVC]

What if F2 is ok but F1 isn't ok and what could give this result ?
Helmut
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Vienna, Austria,
2014-12-10 16:56
(3396 d 03:55 ago)

@ Amira
Posting: # 14046
Views: 5,195
 

 What if F2 is ok but F1 isn't ?

Hi Amira,

What if F2 is ok but F1 isn't ok and what could give this result ?


Welcome to the forum. What if you read the Forum’s Policy you agreed to follow at registration?

What’s your purpose of comparing f1? Product development? For BCS-based biowaivers and pro­por­tio­nality waivers (different strengths) you need only f2.

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Amira
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Egypt,
2015-02-17 20:16
(3327 d 00:35 ago)

@ Helmut
Posting: # 14446
Views: 4,677
 

 What if F2 is ok but F1 isn't ?

Hi Mr.Helmet,
We have regulations in our country to perform a comparative dissolution test before bioequivalence and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant.
What could be done in this case ?

❝ What’s your purpose of comparing f1? Product development? For BCS-based biowaivers and pro­por­tio­nality waivers (different strengths) you need only f2.



Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Helmut
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Vienna, Austria,
2015-02-18 14:23
(3326 d 06:28 ago)

@ Amira
Posting: # 14457
Views: 4,768
 

 In vivo over­rules in vitro

❝ Hi Mr.Helmet,


Helmut, not Helmet. ;-)

❝ We have regulations in our country to perform a comparative dissolution test before bioequivalence…


Not uncommon.

❝ …and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant.


Add a surfactant.

❝ What could be done in this case ?


See above. Note that for BCS classes II/IV in vitro dissolution is rarely predictive of in vivo per­for­mance. Even if you find dissimilar dissolution, products might still be BE. If you are in doubt, run a pilot study. Most agencies require in vitro data, but in vivo BE overrules dissolution.
I’m not familiar with the Egyptian regulation: Do you mean that you are not allowed to per­form a BE study for products lacking dissolution similarity? That would be weird.

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