Alexander
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Romania,
2015-06-29 12:55
(3196 d 01:31 ago)

Posting: # 14995
Views: 7,288
 

 Iron Sucrose Bioequivalence [Study Per­for­mance]

I'm involved in preparing a BE study on 2 different Iron Sucrose formulation and I would like to ask for some information.

Can anyone recommend a laboratory located in Europe which which accurately measures the Total Serum Iron and Transferrin-Bound Iron needed for the pharmacokinetic evaluation?

Thank you in advance for your help.
Ravindra
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India,
2015-07-01 17:29
(3193 d 20:57 ago)

@ Alexander
Posting: # 15005
Views: 5,920
 

 Iron Sucrose Bioequivalence

❝ I'm involved in preparing a BE study on 2 different Iron Sucrose formulation and I would like to ask for some information.


i have handle multiple studies on Iron sucrose for USFDA and Europe submission from protocol to its analysis till successful USFDA audit specifically for Iron sucrose. i am not aware about any lab in Europe with who has method for TBI and TI but if need arise you can contact me and i will help you for this product.


Edit: I activated the e-mail link in your profile. Commercial contacts please off-list. [Helmut]
Helmut
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Vienna, Austria,
2015-07-01 17:53
(3193 d 20:33 ago)

@ Ravindra
Posting: # 15006
Views: 6,042
 

 Suitable matrix?

Dear both,

I’m aware that both the FDA (in a guidance) and the EMA (in current practice) ask for measurement in serum. We all know that serum (or plasma) concentrations are a surrogate of the concentrations at the site of action (which in general is not accessible).
However, Fe stimulates the production of erythrocytes in the bone marrow (hey, the site of action!) of Fe-deficient patients. In my understanding measuring in whole blood would be more reasonable.
Just my 2 ¢.

On another note using stable isotope labelled products (57Fe and/or 58Fe) could help in distinguishing endo­genous from dosed Fe.

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Ravindra
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India,
2015-07-02 10:12
(3193 d 04:15 ago)

@ Helmut
Posting: # 15012
Views: 5,799
 

 Suitable matrix?

❝ However, Fe stimulates the production of erythrocytes in the bone marrow (hey, the site of action!) of Fe-deficient patients. In my understanding measuring in whole blood would be more reasonable.


i am wokring on this projects since last 09 years and had communication with EMEA. i personally think that USFDA guidelines is much appropriate which ask you to measure TBI (transferrin bound Iron) and TI (total iron. IN my terms if you prove both passes your product is really bio equivalent. also it is important to note that ICPMS is not the appropriate method).
Helmut
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Vienna, Austria,
2015-07-02 15:35
(3192 d 22:51 ago)

@ Ravindra
Posting: # 15018
Views: 5,919
 

 Suitable matrix?

Hi Ravindra,

I was taking primarily about the matrix. In this case serum is one step further away from the site of action.
Imagine you consume garlic. Either you could measure alliin or allicin in plasma or allyl methyl sulfide in exhaled air. What would you do?

❝ IN my terms if you prove both passes your product is really bio equivalent.


By (IMHO, erroneously) assuming that total iron is representative of the small amount of absorbed iron on top of the large endogenous pool…

❝ also it is important to note that ICPMS is not the appropriate method.


Why not?

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