A Step by Step Guide to the Drug Development Process

A Step by Step Guide to the Drug Development Process

Written by Deepak Bhagat, In Health, Published On
September 15, 2021

You probably know that all your prescriptions have gone through rigorous testing before being placed in a bottle for you to take. All of that testing ensures that the drug is safe and does what it has been designed to do.

But you probably don’t know the drug development process details that happen before you take your medications. While there may be a few differences from process to process, there are eight basic steps in a drug development guide.

Here is a step-by-step drug development process guide that most new drugs go through, from development to approval.

A Step by Step Guide to the Drug Development Process

  • Discovery and Validation

In this initial process, development companies choose a molecule, gene, or protein to target with a drug. Multiple molecules will be tested, but only those with promise will move on to development.

Roivant Sciences has discussed how they are redefining Big Pharma and the drug discovery process.

  • Preclinical Testing

Preclinical testing involves in vitro and in vivo testing. Examining the molecules interacting in test tubes in the lab is in vitro testing. Testing on animal and other living cells is considered in vivo testing.

It’s in this stage where the efficacy of a drug begins to establish. This safety stage allows the drug to move on to future human trials.

  • Investigational Application Filing

Next, the drug developer will submit an Investigational New Drug Application to the FDA. The FDA will then scrutinize the results by examining the side effects and safety features, the chemical structure, and the manufacturing process.

This is one of the most important steps in the process of developing drugs. Approval from the FDA means the drug can move on to the first round of human trials. After approval, a patented drug exclusivity period begins.

  • Clinical Studies: Phase 1

The first phase of clinical studies has a small group of healthy people. This phase focuses on the safety of the drug.

Phase 1 focuses on how the drug is absorbed, eliminated, the side effects, and whether it produces the desired effect. The maximum tolerated doses are established in this phase of testing.

  • Clinical Studies: Phase 2

In this phase, the patient pool grows from a dozen to over 100 patients. These patients are often people who have the disease that the drug is trying to target.

Safety of the drug and short-term side effects are monitored in this stage. However, it’s important to note whether the drug is working as expected and wanted in this phase. Phase 2 also determines the optimal dose of the drug.

  • Clinical Studies: Phase 3

Phase 3 has even more patients, possibly into the thousands. The study will be designed by the drug developers but must be approved by the FDA. The goal is to ultimately test the success or failure of the drug.

  • New Drug Application

If all goes well through the three phases of the clinical study, then a New Drug Application can be filed with the FDA. There could be 100,000 or more pages that lay out the safety data and research.

It takes about ten months to review the application. If accepted, the drug will get a Prescription Drug User Fee Act, and the FDA will decide.

  • PDUFA Date and Decision

On the PDUFA date, the FDA will release its decision: approve the drug, deny the drug, or request additional information.

If needing additional information, the FDA will state what was lacking and suggestions to remedy the situation for approval. Once approved, the drug becomes available.

  • 8 Steps of the Drug Development Process

Most people don’t give a second thought to all the drugs in their medicine cabinet. They take them for their heart, their blood, their head without having to think about the process that goes into their creation.

The eight basic steps of the drug development process aren’t necessary for everyone to know. But understanding the development can make any user feel more confident in the prescription drugs they take to maintain their health.

If you found this article interesting, check out more health and wellness articles on the blog!

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