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Re: What are FDA laws on Generics? Same %content?

Posted by bassman on June 19, 2006, at 13:28:18

In reply to What are FDA laws on Generics? Same %content?, posted by qbsbrown on June 19, 2006, at 8:21:10

Background: I've worked 25 years in the pharmaceutical industry and I HATE generics. Now I've got that out of the way. :>} The specs for generic drug content are the same as brand name in the US. Perhaps the confusion is that for bioavailability (often, just the concentration of the drug in the serum after dosing), the generic spec is +/-20% of the brand name. That's not as bad as it sounds, because a lot of that 20% is experimental error- it's not a given that two brand name lots would be within 20% of each other in biofluids. But the spec on the tablet, capsule, etc. actual drug content is exactly the same, generic vs. brand.


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poster:bassman thread:658609
URL: http://www.dr-bob.org/babble/20060617/msgs/658710.html