The early phase includes phase I trial which is the first step in testing new medicines developed in the lab. The people who take part in phase I trials amongst the first patients to be given a new treatment.
Phase I trials are the first step in testing a new treatment in humans. The major intent of Phase I studies is to initiate how a particular treatment will act and the protection limits of the treatment. In these studies, researchers look for the finest way to give a new treatment such as by mouth, or injection and how regularly it should be given. They also try to find out the best dose that can be considered safe.
Early Phase Trail Main Objectives/Aim Are:
- The correct dose for new medicines.
- How often the drug should be given to ensure it remains effective.
- The effects the new medicines may have on your body, including side effects and toxicities.
- How your body absorbs, Circulates, changes and eliminates the new medicines.
In Phase I Clinical trials treatment is given to the small groups of patients. After dosage patient are carefully watched for side effects.
Different dosage is given to a different group of the patient i.e.: One group will receive one dosage, and another group will receive another dosage. This process continues in order to find out the highest dose that does not cause harmful side effects. In Phase I clinical trial patients may have lots of blood tests because the researchers look at how your body copes with and gets rid of the drug. They carefully record any side affects you may have and when you have them.
At the end of Phase I trials, it is generally known which doses are good to use and how best to way to carry out the treatment.
