This article will let you know the process which new drugs get approve by FDA, and maket it by the pharmaceutical manufacturers. Pharmaceutical drugs are chemical substances that help to cure, prevent, or relieve the symptoms of illnesses.
What are medicines made from?
Historically medicines have been made from natural sources such as plants, animals, molds, bacteria, and minerals. A lot of medicines are still made from natural sources, especially plants. However, most medicines are “synthetic” medicines. This means that they are made by chemists in labs
Making a New Drug
In order to make a new drug, pharmaceutical companies do a lot of research and testing.
There are certain steps that are usually followed:
1. Research – The first step in making a new drug is research. Scientists study what causes a disease or a symptom. They may study the pathogens (germs) that cause a disease or what makes a certain symptom occur. They then run experiments in the lab to see what chemicals may work. They also use supercomputers to run computer models.
2. Testing on animals – The next phase is testing on animals. Once they have had success in testing on animals, they will apply to the FDA for approval to begin testing on humans.
3. Testing on humans – Testing on humans takes place in three phases.
4. Phase I trials – In the first phase, the drug is tested for safety on a small group of 20-80 people
.
5. Phase II trials – In the second phase, the drug is tested on 100-300 people for efficacy. Efficacy is a measurement of how well the drug works. Some people take the actual drug while others take a placebo. A placebo is just a sugar pill with no real drugs in it. This phase helps researchers determine if the drug is truly effective.
6. Phase III trials – In the third phase, much larger groups of people are tested, typically over 1,000. The effectiveness and side effects are further determined during this phase.
7. New Drug Application – If the trials are successful, then the pharmaceutical company will apply to the FDA for a New Drug Application.
8. FDA Approval – If the FDA approves, then the drug can be sold.
Making a new drug takes many years and typically costs millions of dollars.
Food and Drug Administration (FDA) In the United States, the government has regulations in order to insure that drugs are as safe as possible. Companies must run certain tests and pass requirements before they can sell a drug. The agency that watches over drugs is called the Food and Drug Administration, which is often shortened to FDA.
Types of Drugs
Most legal drugs can be divided into two categories:
1. Prescription – Prescription drugs require approval from a doctor to purchase. They are handed out by pharmacists who insure that the correct doses are given and that people understand the proper way to take the drug.
2. Over the Counter – Over the counter drugs can be purchased without a prescription. Examples of these include pain relievers such as Advil and aspirin, cough syrup, and sinus medicine.
Ways of Taking Drugs
Pharmaceutical drugs can be administered by a number of methods including pills, shots (ouch!), creams, eye drops, inhalers, mists, and through an IV (intravenous).
Side Effects
Most drugs have side effects. You should always read the labels of any drugs you take and follow the instructions, doses, and warnings. If you experience any side effects, stop taking the drug immediately and contact your doctor.
*** NOTE: Just because a drug is “safe” and “over the counter” you must still follow the instructions.
Taking too much of any drug is VERY dangerous and can even kill you.
Kids should never take medicine without the help of a parent, nurse, or doctor.
Interesting Facts about Medicine and Pharmaceutical Drugs
Some medicine tastes bad to discourage children from taking too much of it.
Antibiotics are drugs that kill bacteria.
Some drugs, like vaccines, keep people from getting sick in the first place.
Some drugs help to provide substances that our body can no longer make.
Insulin injections help to replace insulin that the pancreas can no longer make for people that have Type I diabetes.
The scientific name for drugs that reduce pain (painkillers) is “ana
What are medicines made from?
Historically medicines have been made from natural sources such as plants, animals, molds, bacteria, and minerals. A lot of medicines are still made from natural sources, especially plants. However, most medicines are “synthetic” medicines. This means that they are made by chemists in labs
Making a New Drug
In order to make a new drug, pharmaceutical companies do a lot of research and testing.
There are certain steps that are usually followed:
1. Research – The first step in making a new drug is research. Scientists study what causes a disease or a symptom. They may study the pathogens (germs) that cause a disease or what makes a certain symptom occur. They then run experiments in the lab to see what chemicals may work. They also use supercomputers to run computer models.
2. Testing on animals – The next phase is testing on animals. Once they have had success in testing on animals, they will apply to the FDA for approval to begin testing on humans.
3. Testing on humans – Testing on humans takes place in three phases.
4. Phase I trials – In the first phase, the drug is tested for safety on a small group of 20-80 people
.
5. Phase II trials – In the second phase, the drug is tested on 100-300 people for efficacy. Efficacy is a measurement of how well the drug works. Some people take the actual drug while others take a placebo. A placebo is just a sugar pill with no real drugs in it. This phase helps researchers determine if the drug is truly effective.
6. Phase III trials – In the third phase, much larger groups of people are tested, typically over 1,000. The effectiveness and side effects are further determined during this phase.
7. New Drug Application – If the trials are successful, then the pharmaceutical company will apply to the FDA for a New Drug Application.
8. FDA Approval – If the FDA approves, then the drug can be sold.
Making a new drug takes many years and typically costs millions of dollars.
Food and Drug Administration (FDA) In the United States, the government has regulations in order to insure that drugs are as safe as possible. Companies must run certain tests and pass requirements before they can sell a drug. The agency that watches over drugs is called the Food and Drug Administration, which is often shortened to FDA.
Types of Drugs
Most legal drugs can be divided into two categories:
1. Prescription – Prescription drugs require approval from a doctor to purchase. They are handed out by pharmacists who insure that the correct doses are given and that people understand the proper way to take the drug.
2. Over the Counter – Over the counter drugs can be purchased without a prescription. Examples of these include pain relievers such as Advil and aspirin, cough syrup, and sinus medicine.
Ways of Taking Drugs
Pharmaceutical drugs can be administered by a number of methods including pills, shots (ouch!), creams, eye drops, inhalers, mists, and through an IV (intravenous).
Side Effects
Most drugs have side effects. You should always read the labels of any drugs you take and follow the instructions, doses, and warnings. If you experience any side effects, stop taking the drug immediately and contact your doctor.
*** NOTE: Just because a drug is “safe” and “over the counter” you must still follow the instructions.
Taking too much of any drug is VERY dangerous and can even kill you.
Kids should never take medicine without the help of a parent, nurse, or doctor.
Interesting Facts about Medicine and Pharmaceutical Drugs
Some medicine tastes bad to discourage children from taking too much of it.
Antibiotics are drugs that kill bacteria.
Some drugs, like vaccines, keep people from getting sick in the first place.
Some drugs help to provide substances that our body can no longer make.
Insulin injections help to replace insulin that the pancreas can no longer make for people that have Type I diabetes.
The scientific name for drugs that reduce pain (painkillers) is “ana
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