SUMMER SCHOOL ON PHARMACEUTICAL ANALYSIS
The Summer School on Pharmaceutical Analysis
(SSPA) is based on a three-year program on the most advanced analytical
methodologies involved in the launch of new drugs. The SSPA 2011
edition (Cycle II, 1st year) was focused on “Advanced Analytical
Methodologies in Drug Discovery” for characterizing ligand-target
interaction through bioaffinity chromatography with immobilized
target proteins, NMR, MS techniques, luminescence and FRET methods
for ligand screening and hit selection.
The ultimate goal of a drug discovery program is to generate a candidate
drug compound that, besides being active and selective in vitro
on the isolated target, is safe and efficacious in humans. In order
to develop such a compound, many criteria including affinity, activity,
selectivity, physico-chemical properties, and pharmacokinetics must
be optimized. The definition of these criteria involves the availability
and knowledge of appropriate bio-analytical methodologies.
Therefore, following the SSPA 2011, the SSPA 2012 edition (II year)
is oriented on ‘ADVANCED ANALYTICAL METHODOLOGIES IN DRUG
Specifically, the main topics that will be approached during the
parameters in drug development.
The following questions will be addressed: how can the in vivo behavior
of a compound under development be determined? What are its clearance,
half life, distribution and metabolic rate? Which methodologies
can be applied to determine these parameters?
ii) In silico prediction and in vitro determination
of ADMET properties. The following questions will addressed:
how can we predict physico-chemical (PC) and principal ADME (absorption,
distribution, metabolism, and excretion) processes? How can these
in silico parameters be integrated with in vitro pharmacokinetic
(PK) data? Which are the most suitable methodologies to in vitro
determine drug metabolism and distribution?
iii) In vivo determination of ADMET properties:
sample preparation. In in vivo drug metabolism and pharmacokinetic
studies biological samples need to be analyzed. The following question
will be addressed: what are the most efficacious, reliable, accurate
procedures for sample preparation prior to the analysis?
iv) Biomarkers in drug development. The following
questions will be addressed: which methodologies can be used for
rapid and reliable assessment of markers of efficiency and security
of drug under development? Which are the most appropriate analytical
techniques to obtain the fingerprints in a non-target metabolomic
approach? How multivariate data analysis can reveal a good group
clustering and permit the putative assignment of compounds statistically
significant in the classification?
tutorial sessions will focus on practical examples and general solutions
to common problems. The use of LC/MS, GC/MS, and NMR will be described,
such as method development for metabolic products by LC-tandem MS
and its application in mammalian cells and in humans. The potential
and limitations of these techniques together with future perspectives
will be also discussed.
course is open to a maximum of 80 students and is held in English
language.If you already participated at SSPA previous edition(s),
do not miss this opportunity to enlarge your knowledge on the most
advanced bio-analytical methodologies in drug development by attending