What is Phase 1 Clinical Trial in Pharma

by

Before launching any drug product into the market, the drug passes through various phases of clinical trials. Phase 1 clinical trial is one of the phase for the drug.

Phase 1 Clinical Trial:

The ultimate goal of this phase is to determine the safety and efficacy of the new drug entity.

Phase 1 clinical trial is a primary phase. In a phase I clinical trial, a new treatment is tested for safety, side effects, dosage, and timing. In addition, it may help determine how a new treatment should be administered (by mouth, infusion into a vein, or injection) and how it will affect the body.

In order to find the highest dose without causing harmful side effects, the dose is usually increased little by little. A phase I clinical trial consists of a small number of patients who haven’t seen any results from other therapies.

Volunteers who are healthy are sometimes included in these studies. Phase 1 clinical trials are also called phase 1 trials.

Phase I trials are conducted on between 20 and 80 healthy individuals who don’t have any underlying health problems. During this phase, researchers monitor participants closely to determine how their bodies react to the medication.

It is important to keep in mind that preclinical research provides some general information about dosing, but human body reactions to medication can sometimes be unpredictable.

Approximately 80% of medications reach phase 2 clinical trials, according to the FDA.

Conclusion:

The primary purpose of phase 1 trials is to accumulate safety (toxicity) and pharmacological data over a short period of time. There are a small number of patients, very few patients received effective doses, and there are no controls. It is necessary to conduct longer, larger, and controlled studies in order to assess the efficacy and long-term toxicity.

Phase 1 Clinical Trial
Phase 1 Clinical Trial

Also Read:

Refer YT Channel: Pharmabeej