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 The
CDER Guidelines state that a control extraction study must
be performed as part of a drug/device development and it builds
on the information gained as a result of the QCA. The CES
comprises a suite of specifically selected analytical methods
utilising a variety of advanced techniques and methods, and
utilising a range of solvents and conditions.
The
levels of all extractable species are determined and an assessment
as to their likely toxicological impact made with respect
to mode and route of administration.
The
extractables data generated as part of such a “control
extraction study” can be used for
- Specification
of levels of identified species in raw materials on an on-going
basis
- Biological
risk assessment
- Identification
of target analytes for subsequent leachables studies.
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in the details covered here, then why not contact us?
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