There are many drugs on the market, with new ones being created all the time. With so many pharmaceuticals out there, getting one on the market might seem easier than it actually is. However, developing new medicines is a massive undertaking. This rigorous process is to ensure that pharmaceuticals are effective and safe enough to be put on the market for many people. But, what exactly needs to be done to develop new drugs?

The drug development process can be broken down into four key stages. These stages cover everything that needs to be done to put new drugs on the market, from the initial research to it being approved by the FDA. Here’s a breakdown of what the four stages of drug development covers. 

Discovery and Development

The first step in drug development is discovery. When new insights and technologies become available, discovery is possible to find new treatments for diseases. This can begin with thousands of different compounds to start with, which will be narrowed down over time. Once the most promising compounds are determined, the development phase can begin. During development, many details need to be taken into consideration. This includes learning more about what the dosage amount of a drug should be, how effective it is, and potential side-effects, to name a few.

Preclinical Research

Preclinical research needs to be done before a drug can actually be given to people, as it could have the potential to cause serious health problems. This is to ensure that the dosage is correct, and there’s no risk of toxicity. During preclinical research, testing can be done both in vitro and in vivo. For example, drug testing on animals might be done during this stage before a drug can be given to humans. 

Clinical Research

When preclinical research is over, and a drug is ready to be tested on humans, the clinical research stage of drug development begins. Clinical research is the only way of knowing for sure how a person’s body will react to the drug. Planning for clinical research can also require a lot of work, such as how many people will be participating, how long testing will last, and what types of assessments will be conducted during this stage. Anything done during the clinical research stage must also meet FDA standards.

FDA Review

After preclinical and clinical research has shown that a drug is both safe and effective, the developer can submit their research to the FDA. Of course, getting FDA approval of a new drug is key to getting it on the market, so the FDA review is an integral part of developing a drug. To have their medication reviewed, a developer needs to submit a New Drug Application that provides detailed information about their medicine. This application includes all of the developer’s findings from the prior stages. The FDA has six to 10 months to complete the review. Before approving a new drug, the FDA may have additional questions or require more studies. 

Even after the FDA approves a drug, they continue to monitor its safety. To ensure that the drug is safe on the market, they watch over how the drug is being advertised and if any issues arise. Should problems come up with a drug, the FDA can step in.

Reliable Pharmaceutical Development

It’s easy to see how much work goes into developing new drugs. At Tedor Pharma, we can help you throughout this process. Our development services are meant to work for you from start to finish. We know how complex pharmaceutical development is, which is why we offer everything you need so that you can easily rely on us during the entire process. With our services, we’ve helped multiple drugs get approved.

To learn more about how we can help with drug development, contact us today.

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