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Naveen Kumar ☆ India, 2014-09-10 14:34 (4309 d 11:46 ago) Posting: # 13475 Views: 4,790 |
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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 |
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jag009 ★★★ NJ, 2014-09-10 21:51 (4309 d 04:29 ago) @ Naveen Kumar Posting: # 13477 Views: 4,064 |
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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 |
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Naveen Kumar ☆ India, 2014-09-11 08:15 (4308 d 18:05 ago) @ jag009 Posting: # 13481 Views: 3,978 |
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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 |
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jag009 ★★★ NJ, 2014-09-11 22:07 (4308 d 04:13 ago) @ Naveen Kumar Posting: # 13487 Views: 3,992 |
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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 |
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kumarnaidu ★ Mumbai, India, 2014-10-13 14:39 (4276 d 11:41 ago) @ jag009 Posting: # 13691 Views: 3,786 |
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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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