Naveen Kumar
☆    

India,
2014-09-10 14:34
(3487 d 20:05 ago)

Posting: # 13475
Views: 3,238
 

 Teriminal partial AUC for Metformin ER Tablets [Regulatives / Guidelines]

Dear All,

Regarding partial AUCs for Metformin Extended release tablets.

Dosing interval is 24 hours (once daily), as per EMEA modified release guidleine partial AUC will be half of the dosing interval i.e. AUC 0-12, sampling considered is up to 48.00 hours post dose.

Please suggest whether the teriminal partial AUC is AUC 12-24 or AUC12-48.

Regards,
Naveen Kumar.SR
jag009
★★★

NJ,
2014-09-10 21:51
(3487 d 12:48 ago)

@ Naveen Kumar
Posting: # 13477
Views: 2,822
 

 Teriminal partial AUC for Metformin ER Tablets

Hi,

I assume single dose study? If so, partial AUC for the 2nd half would be 12-t (t =48) assuming you collect blood samples from 0-48 hrs. Out of curiosity, are you dealing with generics? If so, why partial AUC on Metformin ER?

John
Naveen Kumar
☆    

India,
2014-09-11 08:15
(3487 d 02:24 ago)

@ jag009
Posting: # 13481
Views: 2,736
 

 Teriminal partial AUC for Metformin ER Tablets

Hi,

Thank you for the prompt response, yes it is a generic product, intended submission is for European Uninon.

As per "Guideline on the pharmacokinetic and clinical evaluation 4 of modified release dosage forms" EMEA, 21 February 2013

lines 797-800 states that

Bioequivalence should be demonstrated by showing equivalence after statistical evaluation of the following parameters:

Single dose: AUC(0-t), AUC(0-∞), Cmax, partialAUC

Please comment, it is not necessary to calculate Partial AUCs for generics (as per your Quote)?

Regards,
Naveen Kumar.SR
jag009
★★★

NJ,
2014-09-11 22:07
(3486 d 12:32 ago)

@ Naveen Kumar
Posting: # 13487
Views: 2,707
 

 Teriminal partial AUC for Metformin ER Tablets

Hi,

Partial AUC assessment is for products with multiphasic drug delivery system (in USA, ie: Concerta, Ritalin LA, Adderall XR, Zolpidem). These products are designed to release drugs in two phases, an IR and an ER burst, for disease treatment strategies. Due to the clinical relevance of the drug release profile, partial AUCs are required to ensure that the generics yield similar drug exposures in the IR and ER portion of the profile relative to the innovator. importance As far as I know Metformin ER does not have such delivery system so Partial AUC is not really need. I ran metformin ER studies in the US and no partial AUCs were needed.

It seems like the EMA statement you quoted is a general statement and is not product specific.

John
kumarnaidu
★    

Mumbai, India,
2014-10-13 14:39
(3454 d 19:59 ago)

@ jag009
Posting: # 13691
Views: 2,529
 

 Epilim Chrono 500 CR tablets

Hi all,
For Epilim Chrono 500 CR tablets which may be given once or twice daily. In this case do we need to calculate early partial AUC(0-6) as well as AUC(0-12)both?

Kumar Naidu
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