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tolerant
exact
1 error
approximate
w/o phonetic transcr.
engl. phonetic transcr.
Search for:
ä
ö
ü
ß
1 result for safety/efficacy
Tip:
To exclude a word:
word1 -word2
German
English
sofern
zutreffend
,
müssen
vom
Antragsteller
ergänzende
Daten
vorgelegt
werden
,
die
die
Gleichwertigkeit
in
Bezug
auf
Unbedenklichkeit
und
Wirksamkeit
unterschiedlicher
Salze
,
Ester
oder
Derivate
eines
zugelassenen
Wirkstoffs
belegen
;
derartige
Daten
müssen
belegen
,
dass
es
zu
keiner
Veränderung
bei
der
Pharmakokinetik
oder
Pharmakodynamik
des
therapeutisch
wirksamen
Anteils
und/oder
bei
der
Toxizität
kommt
,
die
sich
auf
das
Unbedenklichkeits-/Wirksamkeitsprofil
auswirken
könnte
. [EU]
if
applicable
,
additional
data
in
order
to
demonstrate
the
equivalence
of
safety
and
efficacy
properties
of
different
salts
,
esters
or
derivatives
of
an
authorised
active
substance
shall
be
provided
by
the
applicant
;
those
data
shall
include
evidence
that
there
is
no
change
in
the
pharmacokinetic
or
pharmacodynamic
properties
of
the
therapeutic
moiety
and/or
in
toxicity
,
which
could
influence
the
safety/efficacy
profile
.
The example sentences [G] were kindly provided by the
Goethe Institute
.
Sentences marked by [EU] derived from
DGT Multilingual Translation Memory
. The European Commission retains ownership of the copyright in the original data.
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