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The Drug Development Process

A drug goes through many trials before it is approved for public use by the FDA

The Five Stages of the Drug Development Process

The Drug Development Process is the steps a drug goes through to be put out on the market. The process of creating a drug is both long and very expensive.

“Most of the time it takes a really long time to come up with drugs. Somewhere around 10 years. So even though I’ve been out of the industry for 5 years, one of my drugs actually came to market last year,” Dr. James Pruitt, an associate professor at West Chester University, said. Pruitt worked in the pharmaceutical industry as a bench chemist and manager for 23 years. “It’s a lot of money that you spend and the success ratio—once you come up with a drug the chances that you think this is a drug you think will work—the success ratio from that to actually getting it marketed is less than 10 percent. So that means 9 times out of 10 you have a failure.”

There are five steps that go into creating a drug to be approved by the FDA as safe and effective. Created by: Jessica Ferrarelli

The first stage is Discovery and Development. In this stage, new drugs are typically discovered due to new knowledge of diseases, advanced technology, testing of molecule compounds that battle diseases and existing treatments that have unanticipated effects. Thousands of compounds are tested but only a few are considered and experimented on. Some experiments include the best dosage, how it is absorbed, the benefits, the best way to give the drug, side effects and more.

“Generally you make about 10,000 different molecules for any particular drug because of the fact that some of them are not very potent and some of them have problems that can cause other issues,” Pruitt said.

Stage two is Preclinical Research. In this stage the drug needs to be tested in animals before it is tested in humans to make sure it does not cause harm. These tests provide information about dosing and toxicity levels.

“There is a requirement by the FDA that these are tested in both rodent and non-rodent species, which is typically a dog. So it’s either mice and dogs or rats and dogs,” Pruitt said.

Step three in the process is Clinical Research. During this phase, the studies are done in people to see how the drug reacts in the human body. Before they can test in human, a clinical trial needs to be designed and follow a specific protocol. This protocol includes creating research questions and determining who will be part of the study. There are three phases in the clinical trials, ranging from healthy individuals to individuals with the disease as well as an increase in the length of the trials. Each phase tests for something different such as safety, efficacy, side effects and dosage.

“The first studies are actually in healthy humans to make sure that nothing happens to healthy humans when they take this drug and maybe look for side effects if there was an overdose. And then there is a second and third phase of this where they’re looking at larger patients that have this particular disease and is it efficacious for their disease and is it also safe,” Pruitt said.

After the clinical research, and if the drug developer has evidence to support that the drug is safe and effective, it must be approved by the Food and Drug Administration review team in the FDA Review stage. The New Drug Application (NDA) tells the reviewers everything about the drug that they need to know. Everything from preclinical data through all phases of clinical trials must be included along with any other data, safety updates, directions for use, patent information and more. If the review team says the NDA is complete, they have six to 10 months to make the final decision to approve the drug. Once approved, final changes need to be made such as labeling.

In the final step, FDA Post-Market Safety Monitoring, the drug is monitored for months, even years, after it is approved and out on the market for public use. Clinical research provides limited information, so the drug needs to be examined over time. Changes could include formulation, labeling and dosage strength and all changes must be approved by the FDA.

Written By: Jessica Ferrarelli