A chemical compound that is supposed to have some promise as a therapeutic drug is then tested in the laboratory. Animal tests scientists determine a safe dose might be for people. It takes several years to reach even this stage of development.If the drug is still a competitor, then go to Phase II clinical trials. Will be given to people who have the disease for which the drug is intended. Depending on the nature of the disease and chemistry, phase II testing may involve a few dozen or more patients.
A chemical promising is then prepared for testing in humans. It ‘really very brave people, all volunteers who are willing to take medication for the first time. This early diagnosis in humans, known as Phase I is designed to show whether the product is harmful, but the researchers also seek the benefits of the drug.
Once the drug is approved, insurance companies, Medicaid and other government officials who pay for the documents on this subject by the pharmaceutical company. Since most drugs are paid for through insurance policies or the government, this information is essential to ensure that the patient will in fact access to medicines.
But is this process that is at the center of our advances in medicine and who is behind this simple announcement: Today, the FDA approved a new drug that will .
Doctors are warned that the drug has been approved by the marketing and educational materials prepared by the pharmaceutical company. Consumers can learn about the drug through the media. Increasingly, pharmaceutical companies are advertising directly to consumers.
In this case, the agency will approve it, with ultra-detailed labeling that describes how the drug should be used with confidence. When the FDA and pharmaceutical companies agree on the labeling, the drug is approved and sent to pharmacies. To be continued .
But do not stop there. After a drug is approved, companies must continue to monitor its safety. If necessary, new information is added to the labeling, so that doctors and patients can know what are the effects of the drug is having in the general population.
Currently, the drug may have been in development for five to 10 years. At the end of this phase III study, the drug is ready for review by the FDA. The company developing the drug must submit all information to the FDA – literally hundreds of thousands of pages of information on every patient, never exposed to the drug.
The total elapsed time from start to finish is about a dozen years – sometimes more, rarely less. The total cost is estimated that the pharmaceutical industry $ 500 million.
Have you read about it every week – a new drug approved by FDA! Good news. Medical advances allow people to live longer and better. Wondering how a new drug reaches the approval stage and in your pharmacy? Here’s how:
If Phase II is successful, is in Phase III, in which a larger number of patients – sometimes hundreds – of receiving the drug.
These tests will help scientists determine if the drug really works, and in what dose, and for whom.