How medicines are made available?
We all take medicines or drugs whenever we get ill. Have we ever wonder how these medicines are discovered and are made available for people across the globe?
Let us go through following article which will describe the above question.
what does medicines do?
Medicines help patients to recover their disease and improve their quality of life.
In the discovery and development of medicines, patient is the main focus as these are prepared for patients themselves. The research and development process are designed to ensure that new medicines are safe and effective. And also are available for patients in short span of time.
In medicine research and development process, main first step is to identify the best targets for treating a disease. These targets are not humans but the proteins in human body which are normally associated with the disease. We can also say that proteins are the micro-organisms in the patient body causing a disease. These proteins can be many in number and hence, it is a kind of challenge for medicines developer or scientists to identify which protein is relevant and main source of causing a disease. For pictorial view, please refer below image.
Also, at the same time, scientists have to comfirm their(protein) role in disease by means of various and relevant studies. This can also happen sometimes that main protein which caused the disease may transmit its disease casubg capability to other proteins and ultimately affecting the functionality of healthy proteins and causing severe disease. As all these proteins are connected in a path way fashion helps scientist to identify the main culprit causing damage. Based on the disease and its effect on the human body helps in medicine discovery.
There are several procedures of discovering medicines line Hydroput screening or computer based design are used to find chemical compounds that helps in identifying the target. This can be understood in a more easy way that develop such compounds which will be more healthier and powerful and that will connect to damaged compounds or proteins and heal them.
To bring a new discovered medicine in the market, typically, takes an average of 14 years of continuous research, and cost around $2 billion USD. During the research, there can be an instance where lot of medicines are created with different compound structure which may heal one common disease, but only one, which will be most effective) out of the lot will reach the market.
Then that particular medicine is treated on a patient in a preclinical activities and determined medicine's properties and effectivity on the disease by checking metabolism and absorption of medicine by human body. These tests are carried out with proper and carefully to minimize the risks in any way to human body.
Before testing on human body, medicines are tested on animals which play critical role in medicine's discovery. Various tests can be done using experiments or computers, but to understand whether the medicine is safe and effective , tests on animals are very much necessary.
Many medical authorities say that all new medicines are need to be tested on medicines before they are tested on humans. At the same time, while testing on animals, standards set by Animals Community or Animals Welfare needs to be followed.
There are 3 phases of clinical trial program and in each phase, safety and effectivity of medicines are studied and evaluated.
After testing medicines on animals, and once medicines pass animals test, medicines are ready to be tested on humans. In phase 1, medicine is tested on humans in small numbers, say 10 human beings to understand the safety on humans.
In Phase 2, same medicines are given to group of 250 people to determine its effectivity and at the same time, side effects, that are caused by the medicine in any form on human body, are evaluated. These side effects may differ in every patient because of different metabolism and medicine absorption factors.
Sometimes, scientists perform PoC (Proof of Concept) which combines both phase 1 and 2 and medicines are given to limited set of patients and test is continued to assess the medicine.
In Phase 3, large number of patients are recruited for the study (say about 3000 people), in which effectivity of medicine on human body, study of side effects are done and gather all required information.
Once all tests on humans using the medicine are done, final step is to launch the medicine in the market.
to bring the new medicine in the market, every new medicine is required to be registered with health authority like FDI. Registration process includes all clinical information from all three phases compiled with details on safety and effectivity factors to support final intended use of the medicine.
These information on medicine are then compiled according to different regions across the globe and are issued across the globe to make people access the new medicine. Once the registration is approved by the health authority and product is launched, various process starts like monitoring of medicine safety.
This way various medicines come into existence and reach the people.
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