Many people take medicines everyday but not many people know how that medicine evolves from an idea to something that heals certain ailments that plague the human body. They are unaware of testing methods and so on.
Developing a new drug/medicine is a slow and expensive road and ii requires alot r&d pharma, it takes as long as a decade and sometimes millions in order to produce a drug before it gets approved for use. For every successful new drug, about twenty-five thousand chemical compounds are tested, an average of just twenty-five of these go into clinical trial and about five will receive approval for marketing. The watering down is a long process and only the most perfect ingredients are selected for inclusion.
According to a report by the “Tufts Center for the Study of Drug Development”, it costs about 2.6 billion dollars to make a drug that finally receives approval. This goes to show the reason behind the high cost of purchasing these drugs in the market.
Drug discovery always starts with basic research. Scientists often find mechanisms behind cellular receptors and enzymes. For example; research in the 1960s 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 how to fix that imbalance, all thanks to basic research.
Historically, medicines were discovered in nature, like the bark from a special tree which ancient cultures used to relieve pain. It was later discovered that the bark contained a chemical compound which modern pharmaceutical companies used to make Asprin. Today, using genetics and computer models, researchers can quickly predict what compounds will work and create a bunch of samples using specialized robots.
Drugs must go through rigorous testing to make sure they do what researchers suspect and they don’t have overwhelming negative side effects. Not to mention stability studies to check shelf life, storage conditions and so on. These are very essential to make sure that drugs don’t exceed being taken after a time that they’ve expired.
First, compounds must go through phenotype screens or target based screens. This Phenotype screening measures the test compound’s ability to affect cells, tissues or the whole organism; it is on a general level.
Target based screening measures the effect of compounds on a purified target protein in a test tube. This screening is way more specific. It is called an “in vitro assay” and it targets the direct effect a molecule or compound has, down to the protein contained. Even with the best Phenotype screening, the target based screening is way more valuable to the scientists and regulators. Only compounds which show positive activity are developed further. They are made in large qualities and subjected to more tests. Some compounds are even tested on animals and they go on to clinical trials which test the compounds in humans entirely under controlled and highly regulated studies.
The first phase of testing on humans is done to test the safety of the drug. If it’s ultimately safe for human consumption. The second phase focuses on testing the efficacy of the drug; whether it works the way it should. Then finally, phase three conducts double-blind, placebo controlled studies.
After all of these, if the drug does what it’s supposed to do predictably, it is then submitted for market approval.
Infographic provided by The Emmes Company, a rare disease research organization