Class notes
Chapter 1: Introduction
- Course
- Institution
These are my lecture notes from H1. Very handy to make a summary yourself!
[Show more]
Seller
Follow
lisaankersmit
Reviews received
Content preview
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,
Pagina 1 van 2
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller lisaankersmit. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $4.88. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75632 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now