DRUG TESTING, DESIGN,
MARKETING
Drug Discovery
ANCIENT SOURCES

Many drugs still in use today were originally
derived from a plant, animal or mineral source
from hundreds or even thousands of years ago.
DISCOVERY AND CREATION
DISCOVERY

A totally new
chemical can be
discovered in the
environment from
plants, from animals,
from the ocean, or
from the soil.
CREATION

A totally new
chemical can be
derived from
molecular
manipulation of a
drug that is already in
use.

In 1982, human insulin Humulin,
became the first recombinant DNA
technology drug approved by the
FDA
GENTIC MANIPULATION
Recombinant DNA Technology AKA
gene splicing or genetic engineering This process involves using enzymes
in a test tube (in vitro) to cut apart a
segment of a DNA molecule from a
human cell.

STEM CELL THERAPY
Stem cells are immature cells that are capable of
differentiating into ANY type of body tissue.
Stem Cell therapy involves the use of stem cells to
repair or replace damaged cells in the body
GENE THERAPY

In patients who are missing a specific gene or
have an abnormal gene that is the cause of a
disease, gene therapy can be used.
The WORLD’S first gene therapy occurred in
2007.
 A normal version of a gene was used to correct an
inherited disorder of the retina of the eye in a 23
year old patient in England.

WHAT’S IN NAME?
CHEMICAL NAME
 From the moment of
its’ discovery or design
every drug has a
chemical name that is
assigned by the
International Union of
Pure and Applied
Chemistry. This name
describes a drugs’
molecular structure,
distinguishing it from
all other drugs.

Although this name is
used by the drug
companies, this name
is long and
complicated, so the
drug is given a name
that is easier to use
for the general public.
This new name is the .
..
 GENERIC Name

TESTING OF DRUGS
In Vitro Testing
Chemical Testing of a
drug done in a
laboratory in test
tubes is known as In
Vitro testing.
 In Vitro is Latin for
glass

In Vivo Testing


Testing carried out on
animals or humans is
known as in vivo
testing.
In Vivo is Latin for
living
CLINICAL TRIALS


There are three phases of human testing which
are known as Clinical Trials.
Drug Phase I- a group of healthy volunteers (10100) are used to study a safe dosage range,
evaluate side effects, and establish a final correct
dose.
PHASE II AND III



In Phase II, the drug is given on an experimental
basis to about 50 to 500 patients who actually
have the disease that the drug is intended to
treat.
During Phase III, the drug is administered to
several hundred or thousand sick patients
exactly the way in which it would be prescribed
once on the market.
The performance of the drug is compared to other
drugs currently being used to treat the same
disease in order to evaluate its’ effectiveness.
Double Blind Studies are
completed, using a plecebo .
In this type of study, neither
the patient nor the researche
knows which patients are
receiving the drug and which
are receiving a placebo.
PLACEBO: a substance that
has NO pharmacologic effect.
They are “sugar pills” or for
injectibles; normal saline.


The data collected for just one
patient in just one clinical drug trial
can amount to hundreds of pages of
documentation.
The ulcer drug Cimetidine or
Tagamet, is a case in point. After 4
years of testing, the drug company
Smithkline had accumulated a stack
of documents 17 feet high that had
to be taken to the FDA in a truck.
DRUG MARKETING
Advertising for OTC drugs is regulated by the
Federal Trade Commission.
The advertising for Rx drugs is regulated by the
FDA
HOW MARKETING HAS CHANGED:


For many years, drug companies promoted
their prescription drugs by advertising to
physicians in the form of visits from a
pharmaceutical representative, free
samples, promotional literature, and
advertising in medical journals.
Now the “direct to consumer” approach has
become the commonly used form of
advertising a drug.
CONSUMER DRIVEN SHIFT
Consumers
are watching
Ads for
prescription
drugs and are
encouraged
to,”Ask your
doctor if this
drug is right
for You!”
This has
created a
Consumerdriven shift
encouraging
patients to
ask for the
drug of their
choice, rather
than the
choice of their
physician’s.
to-consumer print advertisement;it
was an analgesic.
2004
was the year Cialis was
first introduced to television during a Super
Bowl commercial.
DIRECT TO CONSUMER ADVERTISING
1981was the first direct-
PATENTS
Generic Name –
Original name
assigned
 Trade Name: a
name assigned for
marketing by the
Pharmaceutical
Companies.


The trade name of a
drug is registered
with the U.S. Patent
Office as a registered
trademark. While the
drug remains under
patent, only the
original drug company
has the right to
advertise and market
the drug under that
name.
DRUG WARNINGS AND RECALLS
RECALLS If the FDA deems that
a drug on the market
is no longer safe for
consumers, they may
decide to recall the
drug entirely.

WARNINGS If a drug is
associated with
adverse side effects,
the FDA may elect to
have the drug
company expand the
warning label to
include new
information.

SAFE DRUGS
It is the responsibility of the FDA to monitor
drugs on the market to ensure their safety for the
public.