Vous êtes sur la page 1sur 2

The Journal of Clinical Pharmacology

Bioequivalence or Therapeutic Equivalence

SAGE Publications J Clin Pharmacol 1985 26: 1

Published by:

The Journal of Clinical Pharmacology <a href=http://jcp.sagepub.com/ Bioequivalence or Therapeutic Equivalence SAGE Publications J Clin Pharmacol 1985 26: 1 T he online version of this article can be found a t: http://jcp.sagepub.com/content/26/1/1.citation Published by: http://www.sagepublications.com On behalf of: American College of Clinical Pharmacology Additional services and information for The Journal of Clinical Pharmacology can be found at: Email Alerts: http://jcp.sagepub.com/cgi/alerts Subscriptions: http://jcp.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Downloaded from jcp.sagepub.com by ioana m on November 24, 2010 " id="pdf-obj-0-22" src="pdf-obj-0-22.jpg">

On behalf of:

The Journal of Clinical Pharmacology <a href=http://jcp.sagepub.com/ Bioequivalence or Therapeutic Equivalence SAGE Publications J Clin Pharmacol 1985 26: 1 T he online version of this article can be found a t: http://jcp.sagepub.com/content/26/1/1.citation Published by: http://www.sagepublications.com On behalf of: American College of Clinical Pharmacology Additional services and information for The Journal of Clinical Pharmacology can be found at: Email Alerts: http://jcp.sagepub.com/cgi/alerts Subscriptions: http://jcp.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Downloaded from jcp.sagepub.com by ioana m on November 24, 2010 " id="pdf-obj-0-28" src="pdf-obj-0-28.jpg">

Additional services and information for The Journal of Clinical Pharmacology can be found at:

Downloaded from jcp.sagepub.com by ioana m on November 24, 2010

EDITORIAL Bioequivalence or Therapeutic Equivalence T he recent increase in generic products and the certain high-risk
EDITORIAL
Bioequivalence
or
Therapeutic
Equivalence
T
he
recent
increase
in
generic
products
and
the
certain
high-risk
populations,
such
as elderly
patients,
economic
pressures
to
reduce
health
care
costs
before
approval
is
given
to
a generic
compound.
To
and
thus
mandate
substitution
laws
have
created
a
evaluate
the
untoward
reactions
for
excipients
and
situation
of
considerable
importance.
These
events
binders,
the
clinical
pharmacology
community
must
may
have
outpaced
the
scientific
community’s
ability
take
the
lead
in
postmarketing
surveillance.
We
hope
to
carefully
study
the
scientific
indications.
Clinical
that
the
brief
reports
section
of
THE
JOURNAL
OF
pharmacologists
are
well
aware
of
difficulties
in
will
provide
one
forum
for
CLINICAL
PHARMACOLOGY
determining
the
bioavailability
of
generic
as
well
as
the
timely
reporting
of
such
reactions.
proprietary
drugs.
In
fact,
the
concerns
of
the
scientif-
Generic
drugs
may
offer
a
cOst
advantage.
In
this
ic
community
been
have
a
principal
impetus
in
the
era
of spiraling
health
care
#{244}osts,this
is
an
important
establishment
of
the
bioavailability
standards
by
the
consideration.
However,
the
health
of
our
patients
Food
and
Drug
Administration.
However,
in
the
cannot
permit
a
less-than-thorough
evaluaticm
of
testing
of generic
products,
bioequivalency
studies
are
these
new
additions
to
the
therapeutic
armamentari-
first
conducted
in
vitro
and
then
in
healthy,
young,
urn.
The
challenge
to
the
clinical
pharmacologist
is
to
male
volunteers.
This
may
not
be
an
adequate
evalu-
insure
that
generic
and
proprietary
drugs
are
truly
ation.
We
are
all
aware of
the
possible
exaggeration
of
therapeutically
equivalent.
We
must
form
an
ade-
pharmacokinetic
differences
in patients,
especially
in
quate
clinical
information
base
so
that
we
can
make
a
the
elderly
and
those
with
impaired
hepatic
or
renal
scientifically
reasonable
assessment.
Without
this
function.
When
one
deals
with
life-threatening
condi-
adequate
supply
of
information,
physicians
treating
tions,
pharmacokinetic
differences
in
generic
drugs
patients
cannot
evaluate
the
therapeutic
equivalence
may
lead
to serious
clinical
conseqUences.
Addition-
among
the
generics
or
between
the
generic
and
the
ally,
the
different
excipients
and
binders
that
manu-
proprietary
product.
We
must
know
that
in
vitro
facturers
of generic
compounds
use
may
yield
unto-
bioequivalence
is synonymous
with
clinical
therapeu-
ward
reactions
in
patients.
To
evaluate
the
possible
tic
equivalence.
pharinacokinetic
differences
in
patients
and
also
evaluate
a
drug’s
therapeutic
equivalence,
studies
John
C.
Somberg,
MD,
FCP
should
be
conducted
expediently
in
patients
and
Editor
EDITORIAL
1
Downloaded from jcp.sagepub.com by ioana m on November 24, 2010