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jag009 ★★★ NJ, 2013-08-04 01:23 (4707 d 17:51 ago) Posting: # 11192 Views: 2,720 |
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Hi all, I am working with very strange formulators... Question. Has anyone tried running a BE study with two or 3 lots of a reference product (yes, same country, same product, just a different batch/lot)? If so, what if the study shows 1) test shows BE to all lots of reference 2)test shows BE to 1 or 2 lots of the reference only but failed the other lot + the failed lot doesn't show BE to the other 2 reference lots. Now the question. Has anyone filed such study(s) to FDA/EMA/TPD??? I know, I know, waste of money. But then with products such as Procardia XL which fails on its own (I don't think it's HVD but very close if I am correct)... Can one present the argument and end up with an "acceptable" reply from the agency? Personally I think it's feasible. Does it happen in real life? I dunno. John |
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luvblooms ★★ India, 2013-08-05 08:22 (4706 d 10:52 ago) @ jag009 Posting: # 11197 Views: 2,353 |
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Dear john Approaching FDA, with a BE results using two or 3 lots of a reference product (same country, same product, just a different batch/lot) where even if your product is BE to all except one is futile. Tried once (luckily it was a very small scale pilot) and regretted it!! If you will talk about HVD/HVDP they will simply suggest RSABE.  My two cents!!! — ~A happy Soul~ |
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jag009 ★★★ NJ, 2013-08-05 17:38 (4706 d 01:36 ago) @ luvblooms Posting: # 11205 Views: 2,203 |
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Hi Luvbloom, ❝ Approaching FDA, with a BE results using two or 3 lots of a reference product (same country, same product, just a different batch/lot) where even if your product is BE to all except one is futile. Well I guess it was a good question... Yes but what if the reference lot that you fail BE to also fails against the other reference lots? John |
Ing. Helmut Schütz