Bioequivalence and Bioavailability Forum • Controlled release Product

vatsalasinha
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2009-03-19 12:26
(6300 d 02:25 ago)

Posting: # 3379
Views: 5,981

Controlled release Product [Dissolution / BCS / IVIVC]

Dear Friends,

If there is a generic controlled/ extended release tablet for which we have to conduct a BA study, then as per the guidelines do we have to do a comparative dissolution of both test (Tablet)and reference (capsule) at pH 1.2, 4.5 and 6.8 before starting with the BA study? if the data is available only for pH 6.8 then should we do a comparative dissolution with the rest of the pH i.e. 1.2 and 4.5 also before starting the BA study?

Thanks and Regards

Dr.Vatsala Sinha

kaushalesh
☆

2009-09-18 12:17
(6117 d 03:33 ago)

(edited on 2009-09-18 12:40)
@ vatsalasinha
Posting: # 4215
Views: 4,569

Controlled release Product

Post reply

Dear Vatsala

Multi media dissolution is required for the regulatory submissions, but one can go for the BE study if dissolution is comparable in the discriminatory media. (provided that there is nop safety concerns like dose dumping). Anyway it depends upon the firms internal policy, whether they are ready to go for the BE study with this much level of confidence, (factor in the cost involved)

Regards
Kaushalesh

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]