Poland’s preclinical paragon
Pharmaceutical companies may have to cut R&D
expenditure as a result of the economic
downturn, but they still can’t afford to
let preclinical drug development standards slip
if they
want to survive. IPO Branch Pszczyna explains
how its expertise as a contract research
organisation could provide a much-needed shot
in the arm.
With the present worldwide economic crisis in
mind, it is obvious that pharmaceutical
companies are struggling, with many cutting
costs, particularly those concerning R&D.
One solution to
this problem may be using small contract research
organisations (CROs) that offer competitive prices
and are
flexible in terms of substantive requirements.
One such CRO
is the Institute of Industrial Organic Chemistry,
Branch
Pszczyna (IPO Branch Pszczyna).
Preclinical testing is an important phase in
drug
development, with the main goal being to establish
a
product's ultimate safety profile. Mistakes
made in the
determination of the toxicological profiles of
candidate
compounds can pay off badly in clinical trials,
increasing the
total cost of introducing new drugs to market.
Therefore,
spending fewer resources on preclinical safety
testing does
not seem to be a good strategy; however, in times
of
economic downturn and turbulence, companies tend
to cut
their R&D spending, especially costs that
are connected
directly to preclinical safety testing.
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"Mistakes
in the determination
of the toxicological profiles of
candidate compounds can pay
off badly in clinical trials." |
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The other important issue (particularly in economic
terms) is an ecological risk assessment of active
pharmaceutical ingredients (APIs). It should be
remembered that the presence of APIs in the environment
is being reported worldwide in peer-reviewed scientific
literature. Low levels of APIs are being found
in drinking water, surface water (rivers and lakes),
ground water and sediment. It is generally recognised
that the toxicological safety of the candidate
compound and its ecological risk assessment are
taken into account during drug development. Ecological
risk assessments are performed in compliance with
the European Medicines Agency's guideline on environmental
risk assessment of medicinal products for human
use (EMEA/ CHMP/SWP/4447/00).
A question emerges: how can a firm comply with
all the
legal and economic requirements of developing
a new drug
while keeping costs in the lower range? The answer
may be
to use a small CRO that offers expertise, competitive
prices,
flexibility and a high quality of work, which
is often confirmed
by compliance with good laboratory practice (GLP).
The pull of Poland
IPO Branch Pszczyna is a Poland-based CRO that
provides
preclinical services in the fields of toxicology
and
ecotoxicology. Founded in 1947, it is a leading
R&D centre
that cooperates with domestic and foreign companies
on
toxicological and ecotoxicological studies.
During its 60-plus years of existence, IPO Branch
Pszczyna
has continuously changed and developed. Its assets
are
highly qualified scientific personnel and technicians,
modern
equipment and experience amassed through completed
studies. The company holds GLP certificates that
entitle it to
perform complex toxicological and ecotoxicological
studies
of APIs, and is notified to the national registry
of institutions
entitled to perform experiments with animals.
It offers the
following toxicological services:
- acute toxicity
studies (rats)
- acute eye or skin
irritation studies (rabbits)
- skin sensitisation
tests (guinea pigs)
- sub-chronic/chronic
studies, repeated dose toxicity (rats, mice)
- neurotoxicity studies
(rats)
- reproduction toxicity
studies (rats, rabbits)
- carcinogenicity
studies (mice, rats)
- toxicokinetics
studies (rats)
- local tolerance
tests (rabbits).
Its ecotoxicological services include:
- aquatic toxicology
(fish; crustaceans; sediment-dwelling
dipterans; duckweed; algae)
- soil toxicology
(earthworms; springtails; soil
microorganisms)
- Avian toxicology
(Japanese quail)
- fate and behaviour
in the environment
- analytical chemistry
(analysis of determining the residues
of chemical substances in different matrices).
The scientific studies performed by IPO Branch
Pszczyna's
specialised research teams are solely for domestic
companies.
Its research services are exported to firms in
European
nations, including Germany, Belgium, Holland,
Denmark, UK,
Ireland, France, Czech Republic, Slovakia, Switzerland,
Italy
and Austria. Increasingly, it is cooperating with
businesses in
Australia, Japan, US, South Africa and Israel.
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Company profile
IPO Branch Pszczyna
For further information, visit: www.ipo-pszczyna.pl
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