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  • People take medicine every day, but not many people know how arduous of process that those

  • drugs have to go through to get from idea to your body.

  • Hey guys Julia here for DNews

  • The pharmaceutical industry is big business. According to a study published in the Annual

  • British Journal of Clinical Pharmacology world pharmaceutical sales are approximately 365.6

  • billion dollars. “Big Pharmais often portrayed as the villain. Sometimes rightfully

  • so, think of a recent example of a company acquiring a life saving drug and jacking u

  • p the price 4,000 percent overnight. But it's not always about greed. One of the reasons

  • for the high price of drugs is simply it's so expensive to develop a new one.

  • Developing a new drug or medicine is a slow and expensive road. It can take decades and

  • billions of dollars before a drug ever reaches the FDA -- who then has to approve it for

  • use. According to The Association of the British Pharmaceutical Industry for every successful

  • new drug about 25,000 chemical compounds were tested, on average 25 of these will have gone

  • into clinical trials and just five will receive approval for marketing. And according to a

  • report published by the Tufts Center for the Study of Drug Development (CSDD) it costs

  • more than $2.6 billion to make a drug that finally receives approval.

  • So why does it take so much time and money? Well the FDA, thankfully has established strict

  • guidelines for drug manufacturers as well as, quality control measures like good laboratory

  • practices and guidelines for clinical trials.

  • With that in mind, drug discovery often starts with basic research. Scientists might find

  • mechanisms behind cellular receptors, ion channels and enzymes. For example, research

  • in the 60s on neurotransmitters led researchers to discover an imbalance of brain chemicals

  • might have something to do with depression. Knowing that, drug companies could get to

  • work on a way to fix that imbalance. Shout out to basic research! Woo woo!

  • Historically medicines were discovered in nature, like bark from the willow tree which

  • ancient cultures used to relieve pain. Turns out, the bark contained a compound which modern

  • pharmaceutical companies used to make aspirin.

  • Your granddad's pharmaceutical researcher had to create new compounds by hand,and could

  • only make about 50–100 new compounds every year. But today, using genetics and computer

  • models, researchers can quickly predict what compounds will work and create a bunch of

  • samples using specialized robots. According to a study published in The Pharmaceutical

  • Journal, as many as 10,000 compounds may be considered and whittled down to just 10 to

  • 20.

  • From there, these compounds must be tested. Drugs must go through rigorous testing to

  • make sure they do what researchers suspect and that they don't have overwhelmingly

  • negative side effects.

  • First compounds must go through either phenotypic screens or target-based screens. Phenotype

  • screening measures the test compound's ability to affect cells, tissues or whole organisms.

  • It's pretty general. Target screening measures the effect of compounds on a purified target

  • protein in a test tube, so it's way more specific. It's called an in-vitro assay, and it targets

  • the direct effect a molecule or compound has down the protein. Even with the best phenotype

  • screening, the target-screening is way more valuable to the scientists and regulators.

  • Only compounds which show positive activity are developed further. They are made in larger

  • quantities and subjected to more and more tests. Some compounds are tested in animals,

  • then they go on to clinical trials, which test the compounds in humans in tightly-controlled,

  • highly-regulated studies. Phase one trials test the safety of the new drugs, phase two

  • tests efficacy, and phase three are the holy grail of science: double-blind, placebo-controlled

  • studies.

  • After all of this, if the drug does what's it's supposed to do predictably, it can be

  • submitted to the FDA for market approval. So you imagine with all this time, effort,

  • money and a huge failure rate, pharmaceutical companies tend to focus on drugs they think

  • will have the best financial return.

  • Over on testtube news, I dig deeper into how exactly drug prices are decided here in the

  • United States.

  • Go any other questions about how stuff is made or about the scientific process? Let

  • us know and remember to use the hashtag ASKDNEWS

People take medicine every day, but not many people know how arduous of process that those

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B1 US drug pharmaceutical screening clinical compound approval

How Are New Medications Developed?

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    joey joey posted on 2021/04/14
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