What is Pharmacovigilance and what is its importance?
Posted: Mon Jan 06, 2025 9:32 am
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Written by Maria del Carmen Pastoriza
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Pharmacovigilance is the process of permanent monitoring of medicines , especially after approval of their commercial distribution by health authorities.
Etymologically, the term has a double origin. On the one hand, it comes from the Greek word “pharmakeia” used for drugs, medicines and remedies; on the other, vigilance comes from the Latin “vigilantia” which means vigilance and attentive gaze.
What is the process that a drug follows for its use and distribution?
For a drug to be approved for human use, it goes through a series of stages, or drug cycle:
Phase I: Basic research
At this stage, a substance is proposed as a potential drug and its therapeutic target is established, that is, which molecule the drug is directed at. This stage is complex, since the discovery tunisia phone data of a new drug is not easy, and it is a long process with a very low success rate. It is estimated that only 250 out of every 10,000 molecules from the basic research stage move on to the preclinical research phase.
Phase II: Preclinical
In this phase, the selected compound is analyzed in the laboratory to assess the safety of its administration in humans and its biological activity. The aim is to find out how the drug is distributed or eliminated from the body and to understand its effects, at different doses, on different organs and systems, among other objectives. To do this, tests are carried out on cells in culture, the drug is formulated and pharmacology and toxicology studies are carried out.
Phase III: Clinical
This phase of clinical research is necessary to find out how the drug works in people and to find out if it is a suitable and effective drug in treating the disease, with an optimal safety profile. It is a relatively long stage, where the safety of the compound is demonstrated, the appropriate doses are sought and the efficacy and safety of the experimental treatment are evaluated on a population selected for the study. It provides the basis for the approval of the drug.
Phase IV: Approval and Registration
At this stage, the application for marketing authorization for the drug is submitted to the relevant regulatory agencies.
Phase V: Continued surveillance
Once the drug has been approved and after its commercialization, continuous monitoring is carried out to study its effectiveness and safety in daily clinical use, since, when it comes onto the market, its use expands to thousands or millions of patients around the world, very different from each other, producing conditions and possible interactions not previously identified. This is the pharmacovigilance stage .
Rate this article12345(18 votes)
Written by Maria del Carmen Pastoriza
☛ Send to a friend
Pharmacovigilance is the process of permanent monitoring of medicines , especially after approval of their commercial distribution by health authorities.
Etymologically, the term has a double origin. On the one hand, it comes from the Greek word “pharmakeia” used for drugs, medicines and remedies; on the other, vigilance comes from the Latin “vigilantia” which means vigilance and attentive gaze.
What is the process that a drug follows for its use and distribution?
For a drug to be approved for human use, it goes through a series of stages, or drug cycle:
Phase I: Basic research
At this stage, a substance is proposed as a potential drug and its therapeutic target is established, that is, which molecule the drug is directed at. This stage is complex, since the discovery tunisia phone data of a new drug is not easy, and it is a long process with a very low success rate. It is estimated that only 250 out of every 10,000 molecules from the basic research stage move on to the preclinical research phase.
Phase II: Preclinical
In this phase, the selected compound is analyzed in the laboratory to assess the safety of its administration in humans and its biological activity. The aim is to find out how the drug is distributed or eliminated from the body and to understand its effects, at different doses, on different organs and systems, among other objectives. To do this, tests are carried out on cells in culture, the drug is formulated and pharmacology and toxicology studies are carried out.
Phase III: Clinical
This phase of clinical research is necessary to find out how the drug works in people and to find out if it is a suitable and effective drug in treating the disease, with an optimal safety profile. It is a relatively long stage, where the safety of the compound is demonstrated, the appropriate doses are sought and the efficacy and safety of the experimental treatment are evaluated on a population selected for the study. It provides the basis for the approval of the drug.
Phase IV: Approval and Registration
At this stage, the application for marketing authorization for the drug is submitted to the relevant regulatory agencies.
Phase V: Continued surveillance
Once the drug has been approved and after its commercialization, continuous monitoring is carried out to study its effectiveness and safety in daily clinical use, since, when it comes onto the market, its use expands to thousands or millions of patients around the world, very different from each other, producing conditions and possible interactions not previously identified. This is the pharmacovigilance stage .