Transcript Drug Design & Testing

Drug design and testing,
Drug Names
• Chemical name- describes its molecular
structure and distinguishes it from other
drugs
• Generic name- is determined by the
pharmaceutical company along with the
a special organization known as the
U.S. Adopted names Council
• Trade names or brand name- the
manufacturer selects alone…can
become a registered trademark. They
are they only one who can advertise and
market the drug under that name.
• The particular spelling of a brand name
drug is proposed by a manufacture for
one of several reasons.
To indicate the disease process
being treated
• Azmacort- treats asthma
• Rythmol- treats cardiac arrhythmias
To simplify the generic name
• Pseudoephedrine to Sudefed
• Haloperidol to Haldol
• Ciprofloxacin to Cipro
To indicate the duration
• Slow-K slow release potassium
supplement
Drug Design
• New drugs are discovered in one of two
ways
• Totally new chemical substance
• Derived from molecular manipulation
of a current drug
Drug Design
• Until recently,designing a new
drug by changing the molecular
structure of an existing drug
was a very slow process of trial
and error
Recombinant DNA technology
Gene splicing or genetic engineering
• Aided by computer design and use of
enzymes, researchers are able to
remove DNA chemically from one
organism and transplant into other
Testing
• In vitro- in glass
• In vivo- in living
• many guidelines set by FDA
Animal Phase
• Precedes human testing
• watching for toxic effects,side
effects, addictions, cancerous
tumors or fetal deformities
Animal Phase
• Calculating the Therapeutic Index
(TI)…. The difference between the
dosage that produces a
Therapeutic Effect and the dosage
that produces a Toxic Effect
Animal Phase
• NOT always a reliable indicator
of how well a drug will perform
in humans.
Human Testing
• 3 phases
• 1st phase- Healthy volunteers used to
study a safe dose range, evaluate side
effects and establish a correct dosage.
• Absorption
Phase II
• Drug is given on an experimental
basis to patients with the disease it
will eventually be used to treatdone to determine the extent of it’s
therapeutic effect
Phase III
• Drug is administered to several
hundreds of ill patients in exactly
the way in which it will be used
clinically (dosage & route)
• compared to other current drugs
Phase III Human
• Group A
• all patients disorder and receive
new drug being studied
• results compared to next two
groups for side effects and ability
to treat disorder
Phase III Human
• Group B
• all patients have disorder meant to
be treated by new drug
• all patients receive a placebo and
results are compared to other 2
groups
Phase III Human
• Group C
• all patients have disorder meant to
be treated by new drug
• patients will be treated by another
drug currently being used to treat
disorder
FDA Approval
• After reviewing all
documentation on the safety and
effectiveness of the new drug
• May be protected by a patent for
up to 17 years