Before a new drug is allowed into the market, it first goes through an often rigorous screening and preclinical testing process to ensure its safe for human use. Clinical drug development usually takes years of research and tests. The process typically starts with discovery and development, where research for a new medicine is conducted in the laboratory. Then it enters the next stage that is, preclinical research. Here, the proposed drug is tested on animals and further analysis on safety is done. The third stage which is the most vital part of the process is to administer the new drug on people to test its effectiveness and safety. If the drug performs as it’s supposed to, the goes to the Food and Drug Administration for approval or not. The final stage is to monitor the drug and how it performs in the market.

As earlier mentioned, the third stage of drug development, also known as phase 1 clinical trial, is the most crucial. The main idea for conducting this stage is to test the safety, tolerability of the drug and the right dosage it can be given to people without major side effects. The drug has already been tested on animals and proven to be safe, but side effects in people can always vary. In addition, this phase allows doctors and researchers to determine the most suitable way of administering this drug.

In phase 1 clinical trials, the treatment is tested in three stages, which include, single ascending dose, multiple ascending doses, and the food effect. The first sample group is given a single dose of the drug and closely monitored. If the recipients respond well to the first dose, then doctors gradually increase the dose either within the same sample group or another group of subjects is introduced. Here, the aim is to test the maximum amount of dose individuals can tolerate without serious side effects. The researchers monitor the drug escalation study and collect data on drug absorption, drug utilization and how it the drug distributes in the body.

In phase 1 clinical trials, the research may even take one year. It’s conducted on a small group of subjects between 20 to 80 in the initial stages with aim of establishing side effects and safety. During this phase, other medical research studies are subsequently conducted. These include drug-drug interaction and bioavailability and bioequivalence.

After phase 1 clinical study, the drug then goes through other clinical drug development stages until it’s approved by the FDA for human use.