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Ken

You are being a bit hard on the FDA. These drugs are the same chemical, in the same or similar binder materials, and would already have had chemical tests. They allow plus or minus 20% bio-availability, so it would be very surprising if they weren't found equivalent. Some of the more radical changes such as changes between oral and injectable are more difficult but there would already be a lot of data guiding the required ratio between the two delivery methods. Also a lot of this equivalence testing is a waste of time, as doses don't matter or can be titrated anyway.

Kaiser

Ken: Thanks for the comment. I think there are two separate issues here: you're arguing that most of the bioequivalence testing is pointless, which may be true; and if the margin of error is allowed to be 20%, it in fact may just be a public relations vehicle. Separately, though, given that a policy has been established in which such testing is required to gain approval, I still find it revolting that the entire process seemed to have been usurped and turned into a farce.

Ken

Yes, I had thought that the FDA policy would be that anyone caught cheating should have a prison sentence.

My assumption is that the FDA would have based it's decision on there being some data, just not as much as they thought, that it is not strictly necessary for generics which are identical compounds, and the drugs were already on the market. Regulators have a bad habit of expecting to see tests that they didn't really need.

The requirement for bio-equivalence which is 80-125%, is actually a bit more strict because it is the 90% CI that must lie within those values. It does mean that individuals can have ratios well outside. The only one I did, there were some subjects where the absorption of the generic was much lower, probably due to diet and the generic not having the same physical properties. The average was still within the limits so it was OK. It had actually got through he regulatory process, somehow, but the question was raised about equivalence because of pricing. A cheap drug isn't so cheap if you need more of it.

Drug Test Friend

This doesn't surprise me at all. The FDA has always worked in the best interest of the big pharmaceutical companies.

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