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Each stage of the process must pass strict safety and efficacy testing before the medicine can progress. Throughout all stages the scientists are determining the benefits versus risks of the new drug. For every drug there will be side effects and adverse effects in some patients. In order to determine whether the drug will have an overall benefit, the proportion of patients that respond positively to the treatment must be compared to the number of patients that respond negatively. So for example in a clinical trial sample of 1000 patients, if 996 patients experience a significant improvement in quality of life and 4 patients experience an adverse drug reaction, more than likely the benefit outweighs the risk in this case. If 550 patients significantly improve and 450 patients experience adverse drug reactions the drug is not likely to be marketed. This of course depends on the nature and severity of the adverse events
How do drugs work?
Our bodies are largely controlled by proteins. Proteins exist in many different forms in the body and have many different functions. Each protein has a specific function and is quite specific to the cell type that it acts on. For example, there are specific types of proteins called receptors. Receptors are embedded on the cell surfaces; there are different receptors for different types of cells. A liver cell will have different receptors than a cardiac cell. The receptor binds to other proteins and chemicals on the outside of the cell and this in turn creates a change in the functioning of the cell.
Proteins also act as drug targets. In order for a drug to exert an effect it needs to be bound to a protein. This can be thought of as a lock and key system; where the drugs are the key and the protein is the lock. Once the drug is bound in this lock and key mechanism it can have one of two main influences over the cell. It can produce a change in response or it can stop a normal response of the cell.
Drugs that produce a change in the cell functioning are called agonists. Drugs that stop a normal function of the cell are called antagonists.