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Chapter 1: Introduction
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Chapter 1: IntroductionWhat is Pharmaceutical Medicine?
Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery,
development, evaluation, registration, monitoring and medical aspects (the entire life cycle of a drug)
of the marketing of medicines for the benefit of patients and the health of the community. The
Faculty of Pharmaceutical Medicine is responsible for ensuring and maintaining standards in the
discipline and, as such, has developed a curriculum for higher medical training to equip specialists
with the comprehensive skills and competence increasingly demanded by the industry for the public
good. The European Center of Pharmaceutical Medicine has a competent workforce to provide faster
access to better medicines for patients worldwide.
The drug development process
In the nonclinical research, the
molecule is being tested in a nonclinical
environment (in vitro) and in animals (in
vivo). This consists of the discovery and
the synthesis and formulations (=
production of a specific formulation of a
drug, think about a tablet, liquid,
infusion, injection, etc.). Before going
into the clinical studies, we need to
make sure that the drug can be used
safely in humans. In the United States,
we need to submit an IND
(Investigational New Drug); In Europe,
this is called an IB (Investigated Brochure). The clinical studies are divided into separate phases
(phase I, II and III). In the end, the molecule is hopefully ready to get onto the market. We need to
submit the NDA (New Drug Application), or if the molecule is a biological, we need to submit the BLA
(Biologics License Application). They are both an approval to use the molecule on the market. The
post approval phase is the rest of the life of the drug when it is already on the market, also known as
the phase IV clinical studies.
In the nonclinical research, a GLP (Good Laboratory Practice) needs to be followed: All of the
nonclinical research which is going to be submitted in order to get approval to go into humans, needs
quality standards. So, the GLP is how research should be performed in the laboratory. The GCP (Good
Clinical Practice) are the quality standards in phase I – IV. Those are the international guidelines in
which clinical studies needs to be performed. The GMP (Good Manufacturing Practice) refers to how
the drug is being manufactured (how it is made, produced, synthesized, etc.). Those three practices
are all quality requirements for the drug development.
The drug life cycle
The graph is divided on the
financial matters. The early
part (pre-clinical and clinical
part) costs money, this is an
investment. At the launch,
the drug will be available on
the market. The earnings
afterwards need to cover the
costs of the development,
otherwise you will lose
money. After several years,
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