Naming of drugs - PowerPoint PPT Presentation

About This Presentation
Title:

Naming of drugs

Description:

Assigned Reading Gundersen L The complex process of naming drugs. Annals of internal medicine (1998), 129(8), 677-8. ... and use it under patent law. – PowerPoint PPT presentation

Number of Views:217
Avg rating:3.0/5.0
Slides: 40
Provided by: JohnBu154
Learn more at: https://s2.smu.edu
Category:
Tags: drugs | medicine | naming

less

Transcript and Presenter's Notes

Title: Naming of drugs


1
Naming of drugs
  • A marketed drug has three names a chemical name,
    a generic name, and a brand name.
  • A chemical name is given when a new chemical
    entity (NCE) is developed.

2
  • The chemical name is a scientific name based on
    the compound's chemical structure (e.g.,
    6-thioguanine) and is almost never used to
    identify the drug in a clinical or marketing
    situation.
  • Often, the name is long and difficult to
    pronounce, and, since it has numbers, the number
    in the name might become confused with the
    numbers in the prescription.

3
  • The generic name (or non-proprietary name) is
    granted by the USAN Council and is commonly used
    to identify a drug during its useful clinical
    lifetime.
  • Link

4
  • The generic name does not belong to the company
    that discovers the drug (or owns the patent).
    Once the patent lifetime is expired, any company
    may market the drug under the generic name.

5
  • The generic name must be screened to assure that
    it does not resemble any other generic or brand
    name.
  • The generic name must also be appropriate for the
    class of drug.

6
  • A listing of appropriate drug stem names can be
    found in the National Library of Medicines Drug
    Portal
  • The stems refer to the mechanism of action of the
    drug (not the disease condition)
  • Link

7
(No Transcript)
8
  • The company that patents the drug creates the
    brand name (trademark). This name identifies the
    drug during the 17 years that the company has
    exclusive rights to make, sell, and use it under
    patent law.

9
  • Link
  • Link

10
History of the Pharmaceutical Industry
  • Most of today's major pharmaceutical companies
    were founded in the late 19th and early 20th
    centuries.
  • Key discoveries of the 1920s and 1930s, such as
    insulin and penicillin, became mass-manufactured
    and distributed (penicillin in WW II).
    Switzerlnd, Germany and Italy had particularly
    strong industries, with the UK and US following
    suit.

11
  • Legislation was enacted to test and approve drugs
    and to require appropriate labeling.
  • Prescription and nonprescription drugs became
    legally distinguished from one another as the
    pharmaceutical industry matured.

12
  • Attempts were made to increase regulation and to
    limit financial links between pharmaceutical
    companies and prescribing physicians, including
    by the relatively new US FDA.
  • Such calls increased in the 1960s after the
    thalidomide tragedy came to light, in which the
    use of a new tranquilizer in pregnant women
    caused severe birth defects.

13
(No Transcript)
14
The Sulfanilamide Disaster
  • In 1937, S. E. Massengil Company created an
    elixir (liquid form) of the antibiotic
    sulfanilamide using diethylene glycol as solvent.

15
Ethylene Glycol
Diethylene Glycol
  • Diethylene glycol is a great solvent, but
    extremely toxic.
  • Unfortunately, at the time, there were no legal
    requirement to test the toxicity of the drug
  • This resulted in the deaths of more than 100
    people in the U.S.

16
  • The United States Federal Food, Drug, and
    Cosmetic Act (abbreviated as FFDCA, FDCA, or
    FDC) was passed by Congress in 1938
  • This law gives authority to the FDA to oversee
    the safety of food, drugs, and cosmetics.

17
  • Numerous new drugs were developed during the
    1950s and mass-produced and marketed through the
    1960s.
  • This included the first oral contraceptive, The
    Pill, Cortisone, blood-pressure drugs and other
    heart medications. MAO Inhibitors, chlorpromazine
    (Thorazine), Haldol (Haloperidol) and the
    tranquilizers ushered in the age of psychiatric
    medication.

18
  • Valium (diazepam), discovered in 1960, was
    marketed from 1963 and rapidly became the most
    prescribed drug in history, prior to controversy
    over dependency and habituation.

19
  • In 1964, the World Medical Association issued its
    Declaration of Helsinki, which set standards for
    clinical research and demanded that subjects be
    given informed consent before enrolling in an
    experiment. Pharmaceutical companies became
    required to prove efficacy in clinical trials
    before marketing drugs.

20
  • Cancer drugs were a feature of the 1970s. From
    1978, India took over as the primary center of
    pharmaceutical production without patent
    protection.The industry remained relatively small
    scale until the 1970s when it began to expand at
    a greater rate. Legislation allowing for strong
    patents, to cover both the process of manufacture
    and the specific products, came in to force in
    most countries.

21
  • By the mid-1980s, small biotechnology firms were
    struggling for survival, which led to the
    formation of mutually beneficial partnerships
    with large pharmaceutical companies and a host of
    corporate buyouts of the smaller firms.
  • Pharmaceutical manufacturing became concentrated,
    with a few large companies holding a dominant
    position throughout the world and with a few
    companies producing medicines within each
    country.

22
  • The pharmaceutical industry entered the 1980s
    pressured by economics and a host of new
    regulations, both safety and environmental, but
    also transformed by new DNA chemistries and new
    technologies for analysis and computation.
  • Drugs for heart disease and for AIDS were a
    feature of the 1980s, involving challenges to
    regulatory bodies and a faster approval process.

23
  • Managed care and Health maintenance organizations
    (HMOs) spread during the 1980s as part of an
    effort to contain rising medical costs, and the
    development of preventative and maintenance
    medications became more important.
  • A new business atmosphere became
    institutionalized in the 1990s, characterized by
    mergers and takeovers, and by a dramatic increase
    in the use of contract research organizations for
    clinical development and even for basic RD.
  • 'Big Pharma' confronted a new business climate
    and new regulations, born in part from dealing
    with world market forces and protests by
    activists in developing countries.
  • Animal Rights activism was also a problem.

24
  • Glaxo Wellcome SmithKline Beecham
    GlaxoSmithKline

Merger of Glaxo Wellcome and SmithKline Beecham
creates pharmaceutical giant Alison Abbott,
MUNICH, Munich JONNY EGGITT/FT Garnier to head
Glaxo SmithKline. The merger of the British
pharmaceutical companies Glaxo Wellcome and
SmithKline Beecham, which comes into effect this
summer, creates a giant which could rank number
one in the world in terms of spending on research
and development (RD). It will boast a portfolio
of 30 new drugs and 19 vaccines in clinical
trial. Glaxo Wellcome is currently the
fifth-largest pharmaceutical company in the world
in terms of turnover and SmithKline Beecham is
ranked twelfth. The new company will have a
stock-market value of 110 billion (US180
billion).
25
  • Marketing changed dramatically in the 1990s,
    partly because of a new consumerism.
  • The Internet made possible the direct purchase of
    medicines by drug consumers and of raw materials
    by drug producers, transforming the nature of
    business.
  • In the US, Direct-to-consumer advertising
    proliferated on radio and TV because of new FDA
    regulations in 1997 that liberalized requirements
    for the presentation of risks.

26
  • The new antidepressants, the SSRIs, notably
    Fluoxetine (Prozac), rapidly became bestsellers
    and marketed for additional disorders.

27
  • Drug development progressed from a hit-and-miss
    approach to rational drug discovery in both
    laboratory design and natural-product surveys.
  • Demand for nutritional supplements and so-called
    alternative medicines created new opportunities
    and increased competition in the industry.

28
  • Controversies emerged around adverse effects,
    notably regarding Vioxx in the US, and marketing
    tactics.
  • Pharmaceutical companies became increasingly
    accused of disease mongering or over-medicalizing
    personal or social problems.

29
  • There are now more than 200 major pharmaceutical
    companies, jointly said to be more profitable
    than almost any other industry, and employing
    more political lobbyists than any other industry.
  • Advances in biotechnology and the human genome
    project promise ever more sophisticated, and
    possibly more individualized, medications.

30
Industry revenues
  • For the first time ever, in 2006, global spending
    on prescription drugs topped 600 billion, even
    as growth slowed somewhat in Europe and North
    America.
  • Sales of prescription medicines worldwide rose 7
    percent to 602 billion, according to IMS health,
    a pharmaceutical information and consulting
    company.
  • The United States still accounts for most, with
    252 billion in annual sales. Sales there grew
    5.7 percent.

31
Top Pharmaceutical Companies (sales)
32
Lipinskis Rules of Five
An orally active drug should have the following
  • No More than five hydrogen bond donors
  • No more than ten hydrogen bond acceptors
  • A molecular weight under 500 daltons
  • An octanol-water partition coefficient less than 5

33
How many drug targets are there?
34
(No Transcript)
35
(No Transcript)
36
(No Transcript)
37
(No Transcript)
38
What classes are important?
39
Assigned Reading
  • Gundersen L The complex process of naming drugs.
    Annals of internal medicine (1998), 129(8),
    677-8.
  • http//www.medscape.com/viewarticle/469843
  • (you will need to create a free medscape account,
    and to click on the box at lower right to see all
    4 sections)
  • http//www.fda.gov/AboutFDA/WhatWeDo/History/Produ
    ctRegulation/SulfanilamideDisaster/default.htm
  • Hopkins Andrew L Groom Colin R The druggable
    genome. Nature reviews. Drug discovery
    (2002), 1(9), 727-30.
Write a Comment
User Comments (0)
About PowerShow.com