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Recently read that generics aren't really equivalent but fall within an accepted range of bioequivalence...

Can anyone explain/verify this as well as the process for generic approval?

Thanks!

-Mike
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Mike,

You are essentially right. To market a generic a company must demonstrate equivalence. Then the company does not need to 'reprove' safety and efficacy data.

Bioequivalence can be established via pharmacokinetic data collection. The company must use the same active ingredient and show that the active performs the same in the body i.e. gets into the bloodstream at essentially the same rate and stays there as long (a bit oversimplified, but that's the gist).

Here is an overview from Barr

http://www.barrlabs.com/generic/approval.php

Zz
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merci :)

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Regarding bioequivalence, I would expand a bit on what has been said, to add that the "acceptable range" you speak of can refer to a degree of variance in the amount of drug present in the formulation as compared to the branded medicine.

A hypothetical example: Brand name Drug X is precisely 2.0mg, no more, no less. When you buy it, you know exactly what you're getting, guaranteed. Requirements for the generic version of Drug X are less stringent, and the generic is allowed to have 1.8-2.2mg.

For many drugs this degree of variance may not have significant consequence. In other cases it may: warfarin (blood thinner) and anticonvulsants come to mind as being potentially significant differences b/w branded and generics (but not necessarily the case).

Other differences b/w trade/generic can include rates (or amount) of absorption due to differences in "carrier" composition, that is the stuff that forms the physical pill that is a substance other than the active medication.

Hope this helps.
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I replaced my household's Vicks' VapoRub with CVS' Chest Rub. Both list the same ingredients in the same %. For me, VapoRub is superior to Chest Rub and shall return to VapoRub.

TB
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