How Does a New Medicine Come Into Being?

It is a mistake to think that in the lab, a “crazy” scientist has synthesized another miracle substance, tomorrow they are stamping pills out, the day after tomorrow they sell and have a huge profit. In fact, things are slow, sad and terribly expensive.

But in fact, a new molecule has been found, a future potential cure for some disease. What I’m missing is the fact that the very search for the right molecule is often years of sifting through thousands of similar molecules in search of the one that could potentially be a cure.

What happens next to the molecule? It goes through many stages of testing – preclinical, so-called in vitro and in animals, then the clinical stage in humans. Human studies are also divided into phases: I – studies on healthy volunteers, IIa, IIb, III – directly on patients, IV – post-marketing studies. It is long because all these processes take 5-10 years for each molecule. Sometimes, if the question is about vital medicines, for example, for the treatment of cancer, these procedures can be accelerated, but still, the bill goes for years, not months.

Why is it expensive?

How much does one trial cost, depending on the therapeutic field? So, as you can see, one trial costs from $ 50 million. To register a drug, 10 such tests can be carried out, and in general – as many as required. In total, the cost of withdrawing a drug for registration can be about a billion US dollars, and sometimes even more. That’s why the cost for medications is higher than people expect.

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Why do we need clinical trials, especially on humans, especially on already sick people? The main task of all tests is to answer two questions – how effective a new medicine is and how safe it is. A substance can show efficiency in vitro, but be absolutely ineffective in a living organism, or cause completely different effects for which it was created (in this place everyone recalls the history of Viagra research, which was originally created for the treatment of angina pectoris). Or, for example, the story with chondroprotectors – the hypothesis was good and well-founded, but the research results did not show positive results. So, the need for clinical trials is obvious.

How to conduct testing safely and ethically?

This is where all the fun begins in the clinical trials industry, everything that makes the process so long, expensive and interesting. Since during the XXth century the pharmaceutical industry managed to tarnish itself with a wide variety of violations of ethics and human rights. Now ethics and safety are two sacred points that regulate the process. No, the pharmaceutical industry is a multi-billion dollar business that only thinks about money. This is how they are regulated. All acts regulating testing are based either on millions of dollars in fines in case of violation, or on the threat of banning an already finished product and, as a result, billions of dollars in lost profits.

Category: General

Tags: clinical trials, medications, medicine