hiren379
★    

India,
2012-09-11 08:09
(5040 d 08:33 ago)

(edited on 2012-09-11 08:58)
Posting: # 9170
Views: 7,699
 

 Iron Sucrose [Design Issues]

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Hello friends,

OGD recomendation for Iron Sucrose Injection suggest Parallel design even though the half life is around 6-7 hrs. What can be the rationale for it? :confused::confused:

Along with it they also recommend reference replicate design if one suspects high variability.

Can anyone explain the stand/thinking of USFDA on this?

Regards,
Hiren
 
auditor
★    

India,
2012-09-11 13:31
(5040 d 03:11 ago)

@ hiren379
Posting: # 9176
Views: 6,833
 

 Iron Sucrose

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Dear,

we are facing same problem and searching for same too. :-D:-D

hope we will get answer from anyone of the forum.

thanks,
 
drgunasakaran1
★★  
avatar

2012-09-12 16:40
(5039 d 00:02 ago)

@ hiren379
Posting: # 9186
Views: 6,972
 

 Iron Sucrose

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Dear Mr Hiren,

❝ OGD recomendation for Iron Sucrose Injection suggest Parallel design even though the half life is around 6-7 hrs. What can be the rationale for it? :confused::confused:


Kindly be informed that we need to estimate Total Iron as well as Transferrin Bound Iron for Bioequivalence evaluation of Iron Sucrose BE study as per FDA's Individual Product Recommendation on Iron Sucrose. FDA's Suggestion for Parallel design is not based on the half life of the iron which is around 6 hours. But, FDA's recommendation on Parallel design is based on the Long time taken to eliminate the Transferrin Bound Iron from the body.

❝

❝ Along with it they also recommend reference replicate design if one suspects high variability.


The pharmacokinetics parameters of Total Iron/Transferrin Bound Iron has high Intrasubject Variability. Hence, FDA is suggesting for Reference-scaled average bioequivalence approach.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
 
hiren379
★    

India,
2012-09-12 17:35
(5038 d 23:07 ago)

@ drgunasakaran1
Posting: # 9189
Views: 6,992
 

 Iron Sucrose

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Dear Dr

❝ Kindly be informed that we need to estimate Total Iron as well as Transferrin Bound Iron for Bioequivalence evaluation of Iron Sucrose BE study as per


I have already referred OGD of Iron Sucrose and do know about the analytes to be measured...

❝ FDA's recommendation on Parallel design is based on the Long time taken to eliminate the Transferrin Bound Iron from the body.


Can you provide literature for the same as I have different understanding based on literature available to me????
  1. A study with 59Fe clearly revealed that drug is cleared from plasma 24hrs after drug administration. This also included transferrin bound 59Fe (NDA data)

  2. A bioequivalence study of Fe-sucrose shows below curves for transferrin bound Fe which reveals same concentration at timne 0.00 and 24.00. This even shows that Fe bound to transferrin is cleared by 24hrs.

[image]

Regards,
Hiren
 
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