The
article “As Medicine Evolves, So Too Must Those Who Assure Its Quality”
describes how the U.S. Pharmacopeia (USP) has had to evolve their drug testing
programs to keep up with modern technology. The pharmaceutical world is rapidly
advancing into the world of artificial intelligence, 3D printing, and mobile
apps. This new technology is very exciting, since new drugs and treatments are
being developed that could dramatically improve healthcare. For example, new
pills are being made which can easily dissolve in water or that are reshaped to
make swallowing easier. This idea is crucial for disorders like epilepsy, in
which patients may struggle to take pills in the traditional manner due to
seizures.
So what does this new technology mean for the world of drug quality assurance? Luckily, the USP uses a group of general principles – identity, strength, purity, and performance – which apply to technology in similar ways to drugs. Even though these technological advancements don’t have
the same makeup as drugs do, they can still be tested for the same key values to make sure the patient would be treated properly. The USP plans to hire more technological experts to keep up with new developments.
In his lecture on September 17, 2019, Dr. Michael Decker spoke on just how difficult it is to get a drug through the approval process. One drug must go through research, drug discovery, pre-clinical trials, three clinical trials, and FDA review. He gave the example of Alzheimer’s disease
specifically, which is a neurodegenerative disorder that affects millions of people nationwide. In addition to being an extremely brutal disease, it costs millions of dollars to treat. However, despite its prevalence and cost, there are very few effective medicines for Alzheimer’s disease.
For drug developers, it may be time to dive headfirst into the competitive technological market. It is already difficult enough to get a drug passed through clinical trials, and now the addition of new technology could complicate the process. However, technology is also allowing for new ways
of thinking about drugs that could put innovative drugs on the market. Perhaps new innovation in technology could assist in the creation of drugs to treat diseases like Alzheimer’s. The process is competitive, but the payoff in terms of advancement is more than worthwhile.
Links
References
“As Medicine Evolves, So Too Must Those Who Ensure Its
Quality.” Scientific American, 25 Sept. 2019, https://www.scientificamerican.com/custom-media/usp-science-of-quality/as-medicine-evolves-so-too-must-those-who-assure-its-quality/?mvt=i&mvn=9461564f99b54129b29ba4089944548a&mvp=NA-SCIEAMERLIVE-11237933&mvl=TagLatest
“The Drug Discovery Process: a Brief Introduction from a Biologist’s Perspective.” Neuroscience Seminar. Loyola University Chicago. 17 Sept. 2019.
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