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Re: Potency of Ritalin vs. generic

Posted by djmmm on January 19, 2003, at 9:16:11

In reply to Re: Potency of Ritalin vs. generic, posted by Caleb462 on January 19, 2003, at 1:02:11

Although generic drugs must contain the same active ingredient, legally, the rate and extent of absorption into the blood must be within 20 percent of that for the brand-name drug.

For some people this is significant.

What the FDA says: "Bioequivalence of different formulations of the same drug substance involves equivalence with respect to the rate and extent of drug absorption. Two formulations whose rate and extent of absorption differ by -20%/+25% or less are generally considered bioequivalent. The use of the -20%/+25% rule is based on a medical decision that, for most drugs, a -20%/+25% difference in the concentration of the active ingredient in blood will not be clinically significant."

http://www.fda.gov/cder/ogd/index.htm


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