August 2024 SOCRA Source Journal - Journal - Page 34
Figures
Figure 1. Translational Research
Figure 1. Translational Research
Figure 2. Drug Development
screens and ultimately leads
to early in vivo safety pro昀椀ling.
Lead selection also evaluates
the safety of the pre-leads
in repeated 14-day toxicity
studies and by checking for
cardiovascular safety.
thousands of opportunities for
things to go wrong during the
drug development process.
The Target Product Pro昀椀le, built
during drug discovery, helps
researchers determine where the
drug 昀椀ts within the disease.
Evaluating whether moving to
the pre-lead phase is worth
the time, energy, and money it
will take to develop the drug
is the next step in the preclinical process. After deciding
to move forward with the
clinical trial process, one of
the steps includes assessing
the landscape of the disease,
Figureother
3. Clinical
Trial
including
drugs that
arePhases
already available and how the
new drug could be different.
Researchers also conduct other
assessments before deciding
whether to move forward with
drug development, including
developing the Target Product
Pro昀椀le.
Once there is suf昀椀cient
information from the animal
models, researchers can 昀椀le
an Investigational New Drug
(IND) application or a Clinical
Trial Application. This is the
start of the clinical trial process.
Thousands of opportunities
The Drug Development
Process
If the decision is to proceed
with the idea, researchers begin
the drug development process
(Table 1). Drug development
is a big gamble. There are
It can take 10 to 15 years to get a
drug to market. In the U.S., it can
cost $500 million to $2.6 billion
to complete the process. That
is why it is very important to do
TABLE 1
The Drug Development Process
•
•
•
•
•
•
•
Basic research
Drug discovery:
o Target Product Pro昀椀le
Preclinical
Clinical trials:
o Investigational New Drug application
o Clinical Trial Application
FDA review
FDA approval
Post-marketing research
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identi昀椀ed during the pre-clinical
process are narrowed down to
a handful of candidates. After
the clinical trials have been
conducted, researchers 昀椀le a
submission with results for review
by the U.S. Food and Drug
Administration (FDA). The 昀椀nal
step, hopefully, is FDA approval
to market the drug.
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