Prescription Drug Costs: Who Is To Blame?
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Authors
Gibbs, Richard S.
Issue Date
2010
Type
Thesis
Language
en_US
Keywords
Alternative Title
Abstract
This senior individualized project is experiential based in part on my professional
experience at a contract research organization. There I hold the title of Project Leader for
Laboratory Operations in the Pharmacokinetic department. Pharmacokinetics is a branch
of pharmacology that is dedicated to what happens to externally administered compounds
in living organisms. It is most often applied to pharmaceutical and biotechnical
compounds, and is often studied in conjunction with pharmacodynamics which is what
said drug does to the body. Pharmacokinetics studies the mechanisms of absorption and
metabolism of drug substances, which lends itself to the increased cost of drug
development.
The group that I supervise is responsible for processing biological samples used
for pharmacokinetic and pharmacodynamic evaluation. The studies that are run are
mostly for pharmaceutical and bio-tech firms that vary in size, duration, and complexity.
All of the studies that I am responsible for use animal models as test systems, and have
included species like canines, primates, rodents, swine, ferrets, guinea pigs, and felines.
The entire study process follows a protocol that is written by a study director in
conjunction with a sponsor representative, and may or may not follow Good Laboratory
Practice (GLP) guidelines. GLP guidelines is a uniform 'rule book' used by all
laboratories, and falls under federal scrutiny. Most of the study procedures are spelled
out in the protocol, and for those that aren't, it falls to me to design a study specific
procedure that is suitable to the sponsor, and meets the study requirements. The test
subjects are administered test article, and blood samples are drawn at any number of time
points. The samples are then brought to my area where they are centrifuged and the
plasma or serum is removed. The plasma or serum is most often stored frozen to
maintain the integrity of the sample, and is then shipped frozen to the sponsor, or
internally for analysis. After all the data is collected, a report of finding is generated and
provided to the sponsor. In some studies, an animal necropsy is required to determine the
presence of gross pathological lesions. Necropsies are performed on all the species listed
above, and require specialized training in some cases. Multiple studies may be run for
the same compound based on previous study findings which adds to the overall cost of
the final product. When all is said and done, pharmaceutical and bio-tech companies can
spend $230-$500 million on research and development before a drug reaches the market
(Oppenshaw, 2005). For this reason, it is an important part of my job to help ensure a
rapid turnaround in study performance.
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14 p.
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