HOSPITALS
scale do not translate easily to larger production , and may later on need to be scaled up once more if it is approved for use in the general patient population .
The Phases of Clinical Trials Before any clinical trial can begin , researchers must file an Investigational New Drug ( IND ) application with the FDA . The application includes the results of the pre-clinical work , the candidate drug ’ s chemical structure and how it is thought to work in the body along with a listing of any side effects and manufacturing information . The IND also provides a detailed clinical trial plan that outlines how , where and by
There are three phases to clincal trials whom the studies will be performed .
In addition to the IND application , all clinical trials must be reviewed and approved by the Institutional Review Board ( IRB ) at the institutions where the trials will take place .
• Phase 1 : In Phase 1 trials the candidate drug is tested in people for the first time . These studies are usually conducted with about 20 to 100 healthy volunteers . The main goal is to discover if the drug is safe in humans .
• Phase 2 : In Phase 2 , researchers evaluate the candidate drug ’ s effectiveness in about 100 to 500 patients with the disease or condition under study , and examine the possible short-term side effects and risks associated with the drug . Researchers also analyze optimal dose strength and schedules for using the drug .
• Phase 3 : Once entering Phase 3 , researchers study the drug candidate in a much larger number of patients , typically 1,000 to 5,000 . This phase is key in determining whether the drug is safe and effective and provides the basis for labeling instructions to help ensure proper use of the drug .
12 February 2015