Legal drugs are used as a remedy for lots of diseases, but nobody knows how they are produced. If you have ever asked yourself about this, you will find the answers in article
So, there are five steps to produce a medicine. In this article we are going to explain the steps in order and we are going to talk about them. Let’s start from the first point.
Discovery and develop
We do analysis of diseases. We study the mechanism of that disease: how it works and how affects our bodies. After that, we do several tests and when all is finished, we identificate chemical substances that are believed to have possibilities to be developed like futures effective medications.
Preclinical investigation
Before doing tests on human, the investigators should check that the compound is safe for people to consume. For that, scientists carry out studies in the laboratories using different techniques, such as: in vitro (a process of fertilisation where an egg is combined with sperm outside the body); in vivo (in which the effects of various biological entities are tested on whole, living organisms or cells); and the study of pharmacology and toxicity (the capacity of some substance that can produce harmful effects in the living being).
The preclinical investigation should contribute specific information of possible doses that can be administered and the levels of toxicity. After that, investigators evaluate if the farmac can be tested on human people.
Clinical investigation
It refers to studies or clinical trials that are realized on humans for test how the farmac interacts in human body. Before the beginning of that phase, the investigators need to deliver the IND document (Investigational New Drug) to regulatory agents (FDA in U.S.A., EMA in Europe, and AEMPS in Spain). In IND there are exposed the results of preclinical investigation and the protocol of the clinical trial in humans that is desired to be carried out.
The clinical trials are realized for phases that go from little to big scale:
- First phase: The experimental compound is administered in a little group of patients and voluntaries for evaluate the security of the tractament, determinate the necessary dose and identificate the secondary effects.
- Second phase: In this phase, the experimental tractament its administered to a biggest group of people, to size its effectiveness and value in depth it security.
- Third phase: The farmac its administered to big groups of patients for confirm the efficacy of that compound, see the secondary effects and compare it with others treatments used for that disease.
- Fourth phase: clinical trials that are realized after a farmac has been approved. The objective of this trials is to give additional information about the tractament, the risk, the benefits, etc…
Register and authorization of the authorities
Once the investigators have the results and the analysis of the clinical trials, proceed to send the NDA (National Defence Academy Examination) to the corresponding regulatory authorities. The NDA has all the information about the medicament, where it demonstrates its safety and effectiveness in the studied population. If the authorities approve the security, efficiency and quality of the new tractament, authorization is granted to market it.
Launch and security monitoring
Once commercialized the product, it can realize new clinical trials, like the 4th phase, to determinate it effectivity for other indications, reformulate the medicament to get better or to keep collecting information about adverse effects.
Vocabulary
Develop: To bring out the possibilities
Diseases: A disordered or incorrectly functioning organ, part, structure, or system of the body
Harmful: Causing or capable of causing harm
Trials: The examination of the facts
Desired: Yearned or wished for
Depth: Intensity, as of colour
Launch: Be put on the market
Monitoring: Observing, listening
Webpage
https://www.tucuentasmucho.com/investigacion/desarrollo-medicamentos2/
Macarena Sierra
