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There are illnesses being treated every day, so that means there is also medicine being made to combat those illnesses. A new drug doesn’t just popup over night, it has very strict process it must go through in order to be given to the public. When trying to create a drug, it will not always be successful the first time. There maybe thousands of tests before the final one is chosen and it meets all the criteria strictly enforced by the FDA. These rules are enforced to protect the public from anything that can harm the body when it should be in turn healing it.
The first step to getting a drug onto the market is to first discover the drug and of course create it. Some drugs are just ones that have already been produced but have manipulated to affect a new strain of whatever the drug is being taken for. Although not all drug discoveries start in a lab. More than often they can be discovered in nature among the plants, animals, oceans, and soils of the world. This means that scientists had to realize there are more ways to look at solving a drug ingredient problem.
After a drug is created, it goes through the process of getting a name. Every drug has a chemical name, decided by the International Union of Pure and Applied Chemistry, which describes its makeup and how it’s different from all other chemicals. Due to the chemical names being lengthy and hard to pronounce, the drug companies partnered with the United States Adopted Names Council to come up with something short and sweet and that is where a drugs generic name comes from. With the final approval of the FDA, the last name given to a drug is the trade name. The trade name makes it easier for doctors and patients to remember it and what it is used for. An example of this would be Mucinex, which is used to get rid of mucus in the lungs. These names are usually marked with trademark symbols.
Next is the testing of the drug. To make sure a drug is safe is must be tested by the company until it passes all standards set by the FDA. There are two types of testing for drugs, in vitro testing meaning tested in a lab inside a tube and in vivo testing meaning tests using animals and humans. Before being tested on humans the drug is administered to animals and tested for any side effects, toxic effects, addictions, cancerous tumors, or fetal deformities. Within the testing phase a lot of math is done to describe the action in which a drug produces its effect whether it is a desired or undesired one. This is referred to as pharmacodynamics. Testing the drugs on animals doesn’t necessarily mean it will have the same results on humans so the drug company submits an Investigational New Drug application to the FDA. This is the drug company asking for the FDAs approval to test on humans pending that the animal testing results are all positive and pose no harm. Once the FDA approves, supplies are the sent to clinics to start human testing trials. Human testing involves three phases. The first phase involves volunteers being given the drug to test a safe dosage amount, side effects, and conclude a final safe correct dosage. The first phase lasts between one and one-half years. The second phase includes a larger scale of people who actually have what the drug was made for and how it affects them. This phase lasts at least two years. The third phase is based on an even larger scale and is administered the exact way it will be once final approval. This compares the drug to others already on the market and shows its effectiveness against them. Once all the data is gathered the drug company submits documentation to the FDA and waits for a final decision so they may move onto the manufacturing process.
Once the FDA gives the approval, the drug company can start to manufacture the drug. With the advancing of drugs being made for diseases, today’s manufacturer process strives for good drug quality, sanitation, and how the drug is being packaged. Drugs having the same effects and dosage strength but from different companies still have to contain the same active ingredients and be able to be administered the same way. To prevent the drug from being exposed to the elements there are a few ways to make that happen. In some bottles moisture absorbing gel packs are placed inside to prevent deterioration and to keep them from losing their strength. The label placed on the container must include the expiration date along with a unique number known as a National Drug Code. This number is broken down into three parts and each part represents something different. The first part identifies the drug company; the second part identifies the strength and dose; and the last set of numbers shows the package size and type.
Lastly after the drug has gone through this rigorous process it is ready for marketing. Advertising for new drugs are controlled by two divisions. Prescription drug advertisements are regulated by the FDA while over the counter advertisements are regulated by the Federal Trade Commission. Promotional tactics for drug companies included having their sales representatives visit clinics and provide free samples for patients and giving away take home information to read. As the times have changed, new tactics have widened to ads for drugs being put on TV and advertised in different magazines. These range to over the counter drugs and prescription drugs.
The process starting at the discovery of a drug to the final product being marketed is a long one but every step is crucial to the benefit the drug can have on mankind. This whole process helps keep everyone safe and gives some the chance to lead full lives while living with certain diseases. For every one discovery that’s a great number of lives saved.
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