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Pharmacology for the Health Sciences
Lecture 3
Dr. Steven I. Dworkin
How are Drugs Named?
• Chemical Name
– Specifies chemical structure
• Pre patent or release name
– Typically drug company letters and numbers
• Generic Name
– Nonproprietary name (each drug has only one generic
name)
• Brand or Trade Name
– Market name for a particular company
• Common or Street Name
– Users name
Dr. Steven I. Dworkin
What’s in a Name
Chemical Name
Generic Name
Trade Name
N-(4-hydroxyphenyl) acetamide
Acetaminophen
Tylenol
Diazepam
Valium
4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'fluorobutyrophenone
Haloperidol
Haldol
5-thia-1-azabicyclo [4.2.0]-oct-2-ene-2
carboxylic acid, 7[(aminophenylacetyl)amino]-3-methyl-8-oxo-,
monohydrate
Cephalexin
Keflex, Keforal, Keftabs
DL-threo-2-(methylamino)-1-phenylpropan-1ol
Pseudoephedrine
Sudafed
Cimetidine
Tagamet
7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H1,4-benzodiazepin-2-one
N''-cyano-N-methyl-N'-[2-[[(5-methyl-1Himidazol-4-yl) methyl]thio]ethyl]guanidine
Dr. Steven I. Dworkin
Rose
Chemical Name
isobutylphenyl
propionic acid
In-house name
Generic Name
ibuprofen
Brand Names
Advil, Children's
Advil/Motrin,
Medipren, Motrin,
Nuprin, Pediacare
Fever etc
Street
Non-asprin headache
reliever
Dr. Steven I. Dworkin
ibuprofen (ī'byūprō'fən) , nonsteroidal
anti-inflammatory drug (NSAID) that
reduces pain, fever, and
inflammation. Along with naproxen
and ketoprofen, ibuprofen belongs to
the propionic acid class of NSAIDs. It
was first made available in 1967.
Like other NSAIDs, it acts by
inhibiting the body's production of
prostaglandins. Available over the
counter in a variety of preparations
(e.g., Advil, Motrin, Nuprin), it is
commonly used to treat rheumatoid
arthritis, gout, and painful
menstruation. Side effects include
rash, alteration of platelet function
and bleeding, and intestinal upset,
which can lead to gastritis. Like other
NSAIDS, it appears to have no
potential for abuse or physical
dependence. It should not be used
by those who are allergic to aspirin.
Drug Resources
Dr. Steven I. Dworkin
Classification of Drugs
• Grouping by chemical structure.
Specific Examples
Core Structure
Generic Name
Trade Name
Tetracyclines
Doxycycline
Vibramycine
Corticosteroids
Prednisone
Meticorten
Benzodiazepines
Diazepam
Valium
Dr. Steven I. Dworkin
Classification of Drugs
• Mechanism of action
– Serotonin uptake inhibitors
• antidepressants
– beta blockers
• Anti-hypertensives
– H2 blockers
• Anti-histamines
Dr. Steven I. Dworkin
Drug Classification
Therapeutic Category
• Therapeutic
Categories and
Subcategories
Examples of Subcategories
Analygesics
NSAIDs
Opioids
Antibiotics
Tetracyclines
Penicillins
Cephalosporins
Antihypertensive
b2 –Blockers
Diuretics
ACE Inhibitors
Anti-inflammatory drugs
NSAIDs
Corticosteroids
Asthma Drugs
b2 –Blockers
Corticosteroids
Leukotriene modifiers
Dr. Steven I. Dworkin
Drug Classification
Classification
Characteristics
OTC drugs
Drugs that do not require a
prescription. May contain a lower
dose of a prescribed compound,
Prescription drugs
Greater potential for adverse
effects. Untoward drug interactions
may occur. Use is monitored by a
physician.
Controlled Substances
Schedules drugs evaluated for abuse
liability. More restrictive
requirements regarding distribution,
storage, and record keeping
Dr. Steven I. Dworkin
The Feds
Year
Act
Purpose
Comment
1906
Federal Pure
food act
Prohibit adulteration and
misbranding of
medications
USP standards established for
ingredients. Drug did not have to
be safe or effective
1938
Drug and
Cosmetic Act
Required safety of new
drug approval by FDA
Start of NDA process
1952
DurhamHumphrey
Amendment
Differentiated
prescription and
nonprescription
Drugs unsafe without medical
supervision required
prescription, refill restriction
1962
Kefauver-Harris
Amendment
Required effectiveness of
prescription and
nonprescription approval
by FDA
Drugs developed between 19381962 included
1970
Comprehensive
Drug Abuse Act
Established Categories
for drugs with abuse
potential.
DEA to enforce the act
Dr. Steven I. Dworkin
Dr. Steven I. Dworkin
Dr. Steven I. Dworkin
Dr. Steven I. Dworkin
Pre Clinical Trials
• In vitro studies
• In vivo studies
– Use of standard animal models
• Efficacy
• Potency
• Safety
• LD determination
• ED determinations
– Therapeutic Ratio
• Abuse Potential or Liability
– Drug self-administration
Dr. Steven I. Dworkin
Clinical Trials
•
Introduction
– Before a pharmaceutical company can initiate testing in humans, it must
conduct extensive preclinical or laboratory research.
• Preclinical research typically involves years of experiments in animal
and human cells. The compounds are also extensively tested in
animals.
• 100-300k compounds screens 100-300 compounds 1 or 2 lead
compounds
• Pharmaceutical company provides selected data to the Food and
Drug Administration (FDA) with a requesting approval to begin
testing the drug in humans.
• This is called an Investigational New Drug application (IND).
• Typically this is when the clock starts clicking and the PC has the next
11 years of exclusive patent rights.
Dr. Steven I. Dworkin
Phase
Purpose
Subjects
Duration
Outcome
Phase I
how drug absorbed,
metabolized, and excreted
and side effects over range
of doses
healthy volunteers (20 to
100), who are usually paid
for participating in the
study.
several months
70 percent of experimental
drugs pass this initial phase
of testing
Phase II
determine relative safety of
the new drug, and its
effectiveness.
.
several hundred patients
randomized trials, drug vs
control often blinded.
several months to two years
33 percent of experimental
drugs successfully complete
both phase I and phase II
studies
Phase III
provide drug company and
the FDA with a more
thorough understanding of
the drug's effectiveness,
benefits, and the range of
possible adverse reactions.
several hundred to several
thousand patients., most
phase III studies are
randomized and blinded
trials.
several years
Seventy to 90 percent of
drugs that enter phase III
studies successfully
complete this phase of
testing FDA approval for
market
ing the drug.
Phase IV
objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to
monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to
determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.
Dr. Steven I. Dworkin
Issues
•
•
•
•
•
•
•
•
The New Drug War (non-US markets)
Involvement of Pharmaceutical Companies
Involvement of Interest Groups
Role of advisory panel
Role of FDA officials
Publication and disclosure of negative findings
When things go wrong?
– Cox-2 inhibitors
Media
– Steroids
– Alternative Medications
Dr. Steven I. Dworkin
Questions
• Why are drugs categorized?
• What are the major differences between name brand and generics
drugs?
• Approximately how many drugs are tested for every drug that is
approved ?
• What federal agency is responsible for determining the safety and
efficacy of new pharmaceuticals?
• What federal agency is responsible for enforcing the regulations for
scheduled compounds
• What are the basic differences between OTC and prescription drugs?
• Under what conditions can a schedule I drug be prescribed for a
patient.
• Name 2 Schedule II and 3 Schedule III compounds, what is one major
difference between these compounds (difference of Schedule II
compared to Schedule III) ?
• Who is responsible for the appropriate use of a compound?
Dr. Steven I. Dworkin