The Role of Bioequivalence in Drug Tests

The rising cost of medicines has led many peopleBioequivalence is a comparison of two or more
to patronize cheap non-branded substitutes of theproducts with respect to their bioavailability –
branded medicines they’re using. Becausethe amount of the drug in the bloodstream and
they’re sold at “bargain” prices,how long it takes to get there. When a generic
non-branded or multi-source drugs appear to bedrug is certified as bioequivalent to a brand name
the ideal alternative to the pricey brandeddrug, it means that its active ingredient works in
medicines doctors often prescribe.the same way and in the same amount of time
But experts warn that not all generic substitutesas the innovator drug.
match their branded counterparts in terms ofTo determine its bioequivalence, a non-branded
safety and efficacy. Associating price with qualitydrug is tested for its bioavailability or the rate and
is not always a good idea, especially in the case ofextent of the drug that reaches the general
non-branded drugs. This is because non-brandedcirculation from an administered dosage form.
drugs may not be bioequivalent to the brandedIdeally, non-branded drugs should be bioequivalent
drugs they’re copying.and therapeutically equivalent to the branded
“A building engineer once came to my clinicproducts before they can be substituted for the
and started arguing with my fellows aboutlatter.
bioequivalence because he said generic drugs areIn a market riddled with fake or substandard
the same as branded drugs. I told him ‘If youdrugs, however, that may be a problem. The
make a plan for a building with a measurement ofissue of bioequivalence becomes even more
2.5 millimeters (mm) and somebody changed thatimportant for the patient whose very life depends
to 2.0 mm, what would happen?’ He laughedon the drug he or she is taking. If the
and said ‘That building would collapse!’non-branded drug a person uses doesn’t
That means a teeny-weeny difference couldmatch the branded product, his or her condition
mean disaster,” according to Dr. Ricardowon’t improve. Worse, that individual may
Fernando, a diabetologist and president of thesuffer from serious side effects.
Institute for Studies in Diabetes Foundation.