| Pharmaceutical
compony: A pharmaceutical company, or drug company,
is a commercial business whose focus is to research, develop,
market and/or distribute drugs, most commonly in the context
of healthcare. They can deal in generic and/or brand medicationsare
subject to a variety of laws and regulations regarding the
patenting, testing and marketing of drugs.
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. Switzerland, Germany and
Italy had particularly strong industries, with the UK and
US.
research
and development:
Drug discovery is the process by which potential drugs are
discovered or designed. In the past most drugs have been discovered
either by isolating the active ingredient from traditional
remedies or by serendipitous discovery. Modern Biotechnology
often focuses on understanding the metabolic pathways related
to a disease state or pathogen, and manipulating these pathways
using molecular biology or Biochemistry. A great deal of early-stage
drug discovery has traditionally been carried out by universities
and research institutions.
Drug
development refers to activities undertaken after
a compound is identified as a potential drug in order to establish
its suitability as a medication. Objectives of drug development
are to determine appropriate Formulation and Dosing, as well
as to establish safety. Research in these areas generally
includes a combination of in vitro studies, in vivo studies,
and clinical trials. The amount of capital required for late
stage development has made it a historical strength of the
larger pharmaceutical companies.
The Cost of the inovation:
Drug discovery and development is very expensive; of all compounds
investigated for use in humans only a small fraction are eventually
approved by the FDA. Each year, only about 25 truly novel
drugs (New chemical entities) are approved for marketing.
This approval comes only after heavy investment in pre-clinical
development and clinical trials, as well as a commitment to
ongoing safety monitoring. Calculations and claims in this
area are controversial because of the implications for regulation
and subsidization of the industry through federally funded
research grants.
Controversy about drug development and testing: There have
been increasing accusations and findings that clinical trials
conducted or funded by pharmaceutical companies are much more
likely to report positive results for the preferred medication.
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