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"Performing Test Systems
and Test Items."
This presentation sets forth
the key aspects
of test items and
test systems during the
conduct of studies in
compliance with the principles
of good laboratory practice,
in short, GLP.
As already said in the first
of my three presentations,
I am Sergio Caroli.
I have been one of the
Research Directors of
the Istituto Superiore di Sanita
that is the National
Institute of Health,
where I spent a full 42 years.
In particular, I was the
delegate for Italy at
the Institute Working
Group on GLP from
its new inception in 1988
until I retired in 2010.
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Let us start with
a few definitions.
Do you ever thought what
the successful conduct of
GLP compliance studies is
the proper identification,
characterization,
and management of test
items and test systems.
As the principles of GLP say,
for each study the identity,
including batch number, purity,
composition, concentrations,
or other characteristics to
appropriately define
each batch of
the test or reference
items should be known.
But what do tests and reference
items in test systems
actually mean another
approach should
be adopted to select
a test system.
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The test title is added
to a test system
in a study and is
the subject of an
application for
a marketing permit supported
by the study itself.
The definition given by
the principles of GLP
for test item implies
that the identity,
activities, stability,
and bioavailability of
the test item are central to
the validity of the study.
