What is the process that a drug goes through before reaching the market?

About 50 new drugs are marketed each year. However, before putting the drug on the market, a lot of research needs to be done. In this process those that do not fulfill their function or that have serious contraindications are discarded.

In these years of research (there is talk of more than 10 years for each new drug) about 450 million euros are spent. First of all, look for that before putting a drug on the market, has:

  • Maximum efficiency.
  • Short and long term security.
  • The minimal possible or negligible side effects in relation to its benefit.
  • Easy administration and storage if possible.

All will be studied through different tests, called clinical trials. We will explain it later.

Procedure for placing a drug on the market

Stages in the development of a new drug

The first thing to do when trying to design a new drug is be clear about the effect we are looking for. This means that the disease or problem we want to treat with this new drug must be perfectly known.

Because of this all molecular components must be analyzed that intervene in the disease or biological process in which we are focusing. This process is complicated and tedious but it is essential.

When the target we want it to act on is clear, it’s time to do it search for compound libraries. The compound library is a database where there are millions of compounds and we can make chemical modifications to them with computer systems to get an idea of ​​which ones may be effective and which ones may not.

After choosing several compounds that we think may be effective must be synthesized in the laboratory and must undergo clinical trials.

What is a clinical trial?

A clinical study is a experimental evaluation carried out on a drug before going to the market. It is applied in humans to evaluate the efficacy and safety of the product.

Before clinical trials the new compound must undergo preclinical studies which are performed on animals. A minimum of two animal models is normally required. It aims to evaluate the biological activity of the drug before it is placed on the market.

preclinical studies

preclinical studies

Carry out preclinical studies on a drug before it is placed on the market several parameters must be taken into account AS:

  • Metabolism
  • Dosage range
  • Distribution
  • Adsorption
  • Secretion

Within these tests Acute and chronic toxicity studies are also performed. Acute toxicity is that which occurs in a short period of time which can cause the immediate death of the person who has been exposed to the product.

Conversely, chronic toxicity occurs when long-term symptoms occur after continued exposure to the toxic source.

In addition to toxicity, they must be carried out at this stage reproduction and teratogenicity studies. The latter term refers to the study of teratogenic products, i.e. those that are capable of causing a congenital defect in the fetus during pregnancy.

Once these preclinical studies have been carried out, if the compound in question passes them, we move on to the phase of clinical tests.

Phase I clinical trials: Is the treatment safe?

Phase I trials for a drug before it hits the market is where for the first time people are involved.

The reason that justifies this type of study is to determine the maximum dose that can be taken without serious side effects. While the purported drug’s use has been demonstrated in preclinical studies, it is sometimes difficult to extrapolate the data to humans.

Another utility of conducting phase I clinical trials is decide the best form of administration of the new treatment. This stage usually lasts one to two years.

Phase II clinical trials: is the treatment effective?

Are phase II clinical trials effective?

If once the phase I the new drug is considered reasonably safe, it can be undergo the second phase to find out if the treatment works.

The type of response expected at this stage will depend on what doctors are looking for. For example, it may be that the goal is an improvement in quality of life. Conversely, if it is a tumor, it decreases in size.

In this phase the real efficacy of the drug is established It develops in homogeneous groups of volunteer patients. This will define the minimum effective dose and the maximum tolerated dose. That is, what is the minimum dose that achieves the desired effect and what is the maximum dose that does not produce serious adverse effects.

Phase III clinical trials

The goal of this stage is compare the safety and efficacy of the new drug with another used for the same purposes.

are performed long-term multicenter trials. They usually take two to four years and allow two out of three drugs to be approved.

After evaluating the results, the EMEA or FDA They decide whether the drug is suitable for marketing.

Phase IV: What else should we know?

Phase IV, what else should we know?

once marketed the drug is monitored. Therefore, the long-term effects and the occurrence of adverse effects are studied. stage IV the pharmacovigilance phase can be defined.

Pharmacovigilance is the science that seeks to collect, monitor, investigate and evaluate the information on the effects of the drug. Its goal is to identify information about new adverse reactions and prevent harm in patients.

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