Pharmaceutical Manufacturing: What is a Drug Development Cycle?

It takes about twelve to fifteen years for a new drug to get approved in the United States. This is roughly one-third the duration of the entire professional career for anyone. Next, you probably wonder how much investment it takes to introduce a new drug to the market. It takes approximately one billion dollars. This equals the employment of about six hundred and sixty-five workers at the yearly salary of a hundred thousand dollars for fifteen years.

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The Steps in Drug Development Cycle

The approval of a new drug is a huge undertaking. In addition, picking the right pharmaceutical contract manufacturing company who prioritizes according to your needs and focuses on fast and quality turnaround goes the extra mile to avoid blunders and move your drug’s program closer to success. We have highlighted the steps involved in drug development.

1. Discovery and Development                                      

Although the concept for a new drug might come up as part of a boardroom discussion or over lunch, every drug discovery begins in the lab. A crucial component of drug development is research and development. It forms the foundation for the entire steps that follow.

This first step can lead to the discovery of new insights about an already existing disease, the creation of organic compounds or new chemicals, and new technologies for providing an already existing drug.

2. Preclinical Research

This second step of the drug development cycle works to define a compound’s toxicity. Researchers achieve this by testing it both in vivo and in vitro. During this time, perform trials with dosage and work to define safety metrics.

3. Clinical Research

Clinical research examination is the next step in the process of a drug development cycle. This step involves the examination of a drug’s interactions with the human body. During clinical trials, it is pretty standard for drug trials to be carried out on both animals and humans.

The FDA outlines specific standards for human testing, and it will influence all the phases of the clinical research.

4. FDA Drug Review

FDA drug review is the fourth step in the process of drug development. Here, when a company’s research and trial have been declared, their drug is effective and safe in its intended use. They can go further and file for FDA review and endorsement.

If the FDA approves the drug, the company gains the right to market the drug.

5. FDA Post-Market Safety Monitoring

This is the last step in the process of a rug development cycle. It works to determine drug efficacy and safety throughout its stay in the marketplace. FDA does this by monitoring for issues with over-the-counter or prescription drugs, assessing and approving variations in usage or dosage information. Lastly, they conduct routine inspections of the manufacturing facilities of the drug.

At Sovereign Pharmaceuticals, we are your one-stop shop for all pharma product development, covering formulation development, clinical trials, QA, regulatory, solid dose manufacturing, liquid manufacturing, and everything in between. We've got you covered.