|
Lorr47 -> RE: how much do you Rxs cost per month~ ? (9/27/2008 5:36:00 PM)
|
Pharmaceutically equivalent, bio-available, and bioequivalent.
Pharmaceutically equivalent has taken it in the chin since the FDA cannot inspect the new plants in say China, India and the like. So in the first analysis generics may not be the equivalent of a brand name, and worse yet, one generic may not be the equivalent of another generic.
Bioavailable appears to relate to the rate of absorption. The rate of absorption may not be clinically relevant to a clinical study but make the medication unacceptable to a particular patient.
In bioequivalence studies, the goal of testing is to determine if the drugs are
functionally equivalent. The FDA requires that any approved drug be effective within
a 20% range of the original patented or brand name drug. This means that the
effectiveness may be 20% greater or 20% less effective than the brand name so that
two generic drugs could contain as much as a 40% difference from each other.
Therefore, a drug may be legally chemically equivalent but not at the same time
clinically equivalent. A study run on a generic of the anti-seizure, Tegretol,
found the generic allowed breakthrough seizures.
Since there can be a 40% difference in the drugs just on the bioequivalence issue, I would think that the assumption should be that the drugs will not act the same, especially when you add the absorption and pharmaceutically equivalence issues.
My father took a pain killer called whiskey. I wonder if whiskey is whiskey.
|
|
|
|
