F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]

posted by govardhanpillari – India, 2009-03-04 13:30 (5503 d 13:33 ago) – Posting: # 3314
Views: 28,671

Dear All,

We planned to develop one generic formulation (one formula) for both US and EU submissions. For this, we have done the comparative dissolution studies for both RLD (US and EU). The dissolution data as follows,

S.no  Time  %of drug release
             US RLD  EU RLD
 1     15      62     86
 2     30      94     95
 3     45      98     96
 4     60      99     95
f1   8.78
f2  45.58

Can any one suggest us that if we are matching our test product dissolution profile in between these two RLD profile, Can we succeed in BE with two RLDs.

Sorry for my english....

Thanks in advance...

Regards,
Govardhan


Edit: Table reformatted using BBCodes. [Helmut]

Govardhan.P

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