Drug Bioequivalence Page: 21
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21
4
IT IS NEITHER FEASIBLE NOR DESIRABLE THAT STUDIES
OF BIOAVAILABILITY BE CONDUCTED FOR ALL DRUGS OR
DRUG PRODUCTS, CERTAIN CLASSES OF DRUGS FOR
WHICH EVIDENCE OF BIOEQUIVALENCE IS CRITICAL
SHOULD BE IDENTIFIED, SELECTION OF THESE CLASSES
SHOULD BE BASED ON CLINICAL IMPORTANCE, RATIO OF
THERAPEUTIC TO TOXIC CONCENTRATION IN BLOOD, AND
CERTAIN PHARMACEUTICAL CHARACTERISTICS,
More than 20,000 prescription drug products are
presently available from drug manufacturers. For
only a few of these are there adequate data
documenting their bioavailability in man. Because
of the large number of drug products for which
studies of bioavailability might be conducted, the
enormous number of human volunteers that 'would be
needed, and the large number of clinical investi-
gators and other sciefitific personnel who would be
needed to do the work, it is clearly not feasible
to carry out studies of bioavailability in man for
all drug products.
Furthermore, even were it feasible to do so, it
would not, in our opinion, be ethically justifiable.
The administration of drugs to man is never without
some hazard, although in some cases the risk is
very small. In addition, subjects always experience
some inconvenience and usually some discomfort. It
is axiomatic that these hazards and inconveniences
should not be incurred unless they are outweighed
by the prospective benefits of the studies. When
studies of bioavailability are necessary to insure
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United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel. Drug Bioequivalence, report, July 1974; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39335/m1/24/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.