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- How a Drug Comes
to Market
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- Before a drug is made available to
the American public, pharmaceutical
companies must first complete three
clinical phases (see below), and the
FDA must review the company's
comprehensive drug application.
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- The FDA's policy states that the
agency must be sure the highest
standards of scientific analysis have
been conducted on all proposed drugs,
without shortcuts in a rush to bring a
new "cure" or "treatment" to
market.
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- After arriving at the FDA, the data
is reviewed by a number of experts with
varying perspectives, including drug
safety studies, manufacturing (the FDA
conducts a site visit to the plant to
be sure good manufacturing practices
are in place), and statistical and
medical data from the patients in each
phase of the trials.
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- Additionally, if an adverse event
occurs in another trial with a similar
product, trials using the same or
similar products are evaluated to
determine if there is an increased risk
to patients.
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- Clinical Phases
- Phase 1 studies are designed to
determine the safety of the drug, and
show what the common side effects of the
drug may be and how the drug is
absorbed by, and eliminated from, the
body. Approximately 20 to 80 subjects
are typically involved in this
study.
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- Phase 2 studies begin if Phase 1
studies are acceptable. The goal of
this phase is to see if the drug works
in people who have certain diseases or
conditions. Typically 12 to 300
subjects participate in the Phase 2
study.
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- Phase 3 studies begin if Phase 2
shows the drug to be effective. These
studies collect more information about
the safety and effectiveness of the
drug while studying different dosages
and populations as well as how
effective the drug is in combination
with other drugs. Several hundred to
approximately 3,000 people participate
in the Phase 3 study.
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- After a drug is approved by the
FDA, it may undergo Phase 4 studies,
where new information is studied, such
as new populations, long-term side
effects, or new dosaging.
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- New Biologic
Drug Development
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- Each drug must complete the
following steps in the order as
outlined below:
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Adapted from information provided by
the Food and Drug Administration.
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