SSPA
2010 will be held in Rimini, Italy
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SSPA
2010 - ADVANCED ANALYTICAL METHODOLOGIES IN DRUG PRE-FORMULATION
AND QUALITY CONTROL
This third year of the SSPA course will deal with the most advanced
analytical methods, which are involved in the last phase of drug
discovery and development, which is pharmaceutical manufacturing.
The goal of pharmaceutical manufacturing is the reproducible manufacture
of a safe drug product and is achieved by the controlled “assembly”
and “processing” of “components.” Pharmaceutical
products are manufactured by blending excipients and drug substances
and filling into dosing units, for example, capsules, blisters,
or devices, and the industry has considerable experience of formulating
and manufacturing such products. However, and importantly, to ensure
that the final drug product conforms to an acceptable specification,
there must be robust quality assurance procedures in place for the
components and processes.
The first part of the SSPA 2010 will be dedicated
to ‘Quality control analytical
procedures’ and ‘Method validation’,
which is supposed to be the finishing touch on a proper method development
process.
Fast analytical methodologies will be introduced for pharmaceutical
quality control aiming at method selectivity, impurities characterization
and determination, stability studies.
New analytical methodologies will also be concerned when applied
for bio-equivalence and release studies in the development of new
formulations for modulating sustained drug release. At this regard,
from a scientific standpoint, excipients offer the pharmaceutical
scientist challenges in terms of material and bulk properties characterization
and inter and intra brand, supplier, and supply chain consistency,
with obvious implications for functionality and, importantly, quality.
‘Method
validation’ is the process of proving that
an analytical method is acceptable for its intended purpose. In
order to resolve this problem, the speakers of this school describe
regulatory or guidance documents, and therefore the validity of
the analytical methods dependent on the guidance, terminology and
methodology, proposed in these documents. It is therefore of prime
importance to have clear definitions of the different validation
criteria used to assess this validity. It is also necessary to have
methodologies in accordance with these definitions and consequently
to use statistical methods which are relevant with these definitions,
the objective of the validation and the objective of the analytical
method. The main purpose of this part of the school, is to outline
the definitions of the criteria and the experimental procedures
proposed to evaluate those criteria in the validation of analytical
methods in the pharmaceutical field.
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