sarsXdave
Bluelighter
I don't know if this site is considered super credible, but here:
http://www.medscape.com/viewarticle/410695_7
EDIT: I noticed the direct link doesn't work without a login. Just go here and pick the third result from the top:
http://www.google.com/search?q=fda+...s=org.mozilla:en-US:official&client=firefox-a
It discusses how, generics WERE allowed to vary by 20% either way, until the 1980s. They have apparently moved to new statistical measures, but it's not exactly the same as so many people on BL like to claim either.
I was somewhat wrong as are you. Just because the FDA says they are the same doesn't mean they are, it means they fall into some government-regulated margin of error that's considered "same-enough" like all products. Again, I admit that I was somewhat wrong, but it wasn't based on some high school pillhead legend.
Here's FDA's current statistical idea to approve of something as "bioequivalent," if some don't want to click the link:
"I. When the current rule was adopted in 1986, if both the upper and lower limits of the CI were within 20% of the reference mean (80% to 120% ), the generic product was declared bioequivalent to the reference product. In 1992, the FDA issued a guidance in which the use of log-transformed data and an upper limit of 125% were adopted. These criteria remain the current rule for bioequivalence decisions."
EDIT: I just realized I phrased one of my above posts funnily. I meant it had to be AT LEAST 80% (I guess "within 20%" would've been the right way to say it). The way I said it, I'm sure it sounded like a pretty big potential difference.
http://www.medscape.com/viewarticle/410695_7
EDIT: I noticed the direct link doesn't work without a login. Just go here and pick the third result from the top:
http://www.google.com/search?q=fda+...s=org.mozilla:en-US:official&client=firefox-a
It discusses how, generics WERE allowed to vary by 20% either way, until the 1980s. They have apparently moved to new statistical measures, but it's not exactly the same as so many people on BL like to claim either.
I was somewhat wrong as are you. Just because the FDA says they are the same doesn't mean they are, it means they fall into some government-regulated margin of error that's considered "same-enough" like all products. Again, I admit that I was somewhat wrong, but it wasn't based on some high school pillhead legend.
Here's FDA's current statistical idea to approve of something as "bioequivalent," if some don't want to click the link:
"I. When the current rule was adopted in 1986, if both the upper and lower limits of the CI were within 20% of the reference mean (80% to 120% ), the generic product was declared bioequivalent to the reference product. In 1992, the FDA issued a guidance in which the use of log-transformed data and an upper limit of 125% were adopted. These criteria remain the current rule for bioequivalence decisions."
EDIT: I just realized I phrased one of my above posts funnily. I meant it had to be AT LEAST 80% (I guess "within 20%" would've been the right way to say it). The way I said it, I'm sure it sounded like a pretty big potential difference.
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