Page 31 - Drug Discovery and Development: Prospects and Challenges

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Brothers and sisters,
Ladies and Gentlemen,
Brothers and sisters,
Ladies and Gentlemen,
Drug Development Process
DRUG DEVELOPMENT PROCESS
According to the Food and Drug Administration (FDA), drug discovery
According to the Food and Drug Administration (FDA), drug discovery and development
and development involve five stages: discovery and development, pre-
involve five stages: discovery and development, pre-clinical research, clinical research, FDA review,
clinical research, clinical research, FDA review, and post-marketing
and post-marketing surveillance (US FDA, 2020). The concise step is provided in Figure 19.
surveillance (US FDA, 2020). The concise step is provided in Figure 19.

POST
MARKETING

Figure 19: Drug discovery and development chart
Figure 19: Drug discovery and development chart

The drug development process began in university laboratories, where research groups are s,
The drug development process began in university laboratorie
where research groups are awarded research grants from government
awarded research grants from government agencies or pharmaceutical industries to carry out
agencies or pharmaceutical industries to carry out fundamental research
fundamental research to understand a particular disease. Once the potential target has been identified,
to understand a particular disease. Once the potential target has been
experimental procedures and lab testing are performed. Historically, researchers would identify
identified, experimental procedures and lab testing are performed.
potential compounds from natural sources, such as plant, animal, microbes, and marine products. As
Historically, researchers would identify potential compounds from
many as 10,000 compounds are found to exhibit potential biological activities for drug application.
natural sources, such as plant, animal, microbes, and marine products.
The process continues to progress to a pre-clinical study using in vitro and in vivo techniques, resulting
As many as 10,000 compounds are found to exhibit potential biological
in less than five compounds to proceed with the clinical trial. After a long and laborious journey, only
activities for drug application. The process continues to progress to a
one drug candidate will pass the FDA review before its official release into the market (Torjesen,
2015). pre-clinical study using in vitro and in vivo techniques, resulting in less
than five compounds to proceed with the clinical trial. After a long and
laborious journey, only one drug candidate will pass the FDA review
before its official release into the market (Torjesen, 2015).

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