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Drug Development Process-1

The drug development process consists of 5 steps according to the FDA: 1) discovery and development where researchers test compounds and conduct experiments, 2) preclinical research involving laboratory and animal testing, 3) clinical research involving human trials, 4) drug review where the FDA approves or rejects the drug application, and 5) post-market drug safety monitoring where the FDA oversees problem reports. Some challenges are the lengthy process, unknown disease mechanisms, and increasing costs and pricing pressure, but partnerships, adaptive designs, and big data may help address these challenges.

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449 views12 pages

Drug Development Process-1

The drug development process consists of 5 steps according to the FDA: 1) discovery and development where researchers test compounds and conduct experiments, 2) preclinical research involving laboratory and animal testing, 3) clinical research involving human trials, 4) drug review where the FDA approves or rejects the drug application, and 5) post-market drug safety monitoring where the FDA oversees problem reports. Some challenges are the lengthy process, unknown disease mechanisms, and increasing costs and pricing pressure, but partnerships, adaptive designs, and big data may help address these challenges.

Uploaded by

Ima An
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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DRUG DEVELOPMENT PROCESS

There are five steps in the drug development process, according to


the FDA.

1. Discovery and development


In this step, researchers examine new insights into a disease
process, which allows them to design a product to stop the effects of
the disease.

They test molecular compounds to find possible beneficial effects


against certain diseases.

Researchers discover new drugs through existing treatments and


new technologies as well.

Then, they conduct experiments to gather information on how the


drug is absorbed, distributed, metabolized, and excreted.
They also discover its

Potential benefits

Mechanisms of action

The best dosage and the best way to give the drugs

Side effects of adverse events, how it affects different groups of


people

How it interacts with other drugs and treatmentsits effectiveness


compared to other drugs.
2. Preclinical research
The second step in the is preclinical research, which includes in
vitro and in vivo trials.

In the preclinical research step, drugs go through laboratory and


animal testing to answer basic questions about safety.

In this step, FDA requires researchers to use laboratory best


practices as defined in medical product development regulation to
test safety.

These regulations include study conduct, personnel, facilities,


equipment, written protocols, operating procedures, study reports,
and a system of quality assurance oversight for each study.
3. Clinical research
The third step is clinical research. This refers to studies or trial that are done
in people.

Through clinical research, specific questions related to a medical product are


answered.

Through these answers, researchers decide who qualifies to participate, how


many people will be apart of the study, how long the study will last, a control
group, how the drug will be administered,

What assessments will be conducted, and how the data will be reviewed?
4. Drug review
The fourth step of the process is the FDA drug review.

First, a pharmaceutical company submits a New Drug


Application

FDA reviews the drug and approves or rejects it.

Finally,an FDA advisory committee provides their input.


5. Drug safety monitoring

The last step in the drug development process is FDA


post-market drug safety monitoring.

This is where FDA reviews reports of problems with drugs

Can decide to add cautions to the dosage or usage


information, as well as other measures for more serious
issues.
DRUG DEVELOPMENT CHALLENGES
Pharmaceutical industry faces a host of drug development challenges.

Main challenges is the lengthy process, according to the National


Institutes of Health (NIH) Due to the lengthy process, NIH states, there is
a high degree of uncertainty that a drug will actually succeed.

 Many disorders have unknown pathophysiology, it is oftentimes


difficult for researchers to target identification.

Another major challenge in the drug development cycle, according to


experts in the pharmaceutical and drug development field, is increasing
costs and pressure on pricing.
But experts believe that public-private partnerships,
adaptive designs, and big data can help improve this
pressure.

Public-private partnerships come in different forms, each of which


offer specific opportunities and face distinct challenges.

Adaptive trial designs are also beneficial because they allow


modifications to the trial after its initiation without undermining its
validity. But these designs require careful planning and
specification before a trial starts.

The use of big data is vital for researchers to leverage existing


information into knowledge usable for drug discovery and
development.

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