Bioequivalence and Bioavailability Forum • F1 and F2 values and dissolution profile

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

posted by govardhanpillari – India, 2009-03-04 13:30 (5913 d 00:48 ago) – Posting: # 3314
Views: 30,709

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

Complete thread:

F1 and F2 values and dissolution profilegovardhanpillari 2009-03-04 12:30 [Dissolution / BCS / IVIVC]
- F1 and F2 values and dissolution profile drcampos 2009-03-04 13:51
- F1 and F2 values and dissolution profile Aceto81 2009-03-05 12:30
  - F1 and F2 values and dissolution profile Helmut 2009-03-05 14:01
  - F1 and F2 values and dissolution profile govardhanpillari 2009-03-06 06:04
    - F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
      - F1 and F2 values and dissolution profile govardhanpillari 2009-03-07 05:47
- US RLD / European reference Helmut 2009-03-05 14:15
  - European reference Ohlbe 2009-03-05 19:09
- F1 and F2 values and dissolution profile jayeshd 2010-04-17 08:58
  - EU + US Ohlbe 2010-04-17 20:19
  - F1 and F2 values and dissolution profile Dr_Dan 2010-04-19 14:51