Skip to content

The 5 Phases of the Drug Development Process

The 5 Phases of the Drug Development Process

Have you ever wondered how drugs become available on the market? Whether the pharmaceutical company develops its drugs in-house or hires a contract manufacturing organization to develop its products, each pill, from over the counter aspirin to prescribed medications, is made by following a specific process.

Here are the five phases of the drug development process that each drug you have ever encountered has gone through.

The Discovery and Development Phase

The first phase in the drug development process is discovery and development. Discovery occurs through gaining insights on diseases or compounds that may have therapeutic effects for specific ailments.

The development portion of phase one includes researching the compound in question to determine how the body absorbs and metabolizes it, possible side effects it may have, and how it impacts people differently. This stage also requires research regarding the best dosage, the correct delivery method, and the overall benefits of a specific drug.

The Preclinical Research Phase

The preclinical research phase tests the drug to determine if it is safe to move forward with testing on human subjects. These trials are done on non-human subjects to assess the efficacy and toxicity and gather further information on the drug.

The Clinical Research Phase

After a drug passes the preclinical phase, it can move on to clinical research. This phase uses three trials that continuously increase the number of participants to study the drug’s effects on a wide array of subjects.

The FDA Review Phase

If the drug has proven to be safe and effective on human subjects, it then moves on to FDA approval. The FDA will examine the lab’s application and collected data from the previous phases to decide if a drug is safe for the market or not.

The FDA Post-Market Monitoring Phase

Even after a drug is approved, it must still be monitored as efficacy and safety information can change as more users take it. Therefore, while on the market, the FDA will review problems to ensure cautionary messages about dosage and side effects are available to users. The FDA may also recall the drug if more serious illnesses occur.

All pharmaceutical manufacturers must follow the five phases of the drug development process to ensure safe and effective medications are available on the market.

Leave a Comment