Thousands of medications are on the market, and new ones are being developed continuously. With so many medicines already on the market, getting one on the market may seem simpler. Developing new drugs, on the other hand, is a big job. We have blogs that talk about the importance of each development step, including the advantages of post-approval research and development.
This rigorous procedure ensures that drugs are effective and safe enough to be available to many people. But what precisely must be done to create new drugs?
The drug development process can be divided into 4 parts. These phases contain all that must be done to bring new medications to market, from early research through FDA approval. The 4 stages of drug development are summarized here:
Development and Discovery
The discovery process is the initial stage in medication development. New illness therapies may be discovered when new insights and technology become accessible. This can start with hundreds of distinct chemicals that will be whittled down over time. The development phase can begin once the most promising molecules have been identified. Many things must be considered throughout the development process; this involves knowing more about a drug’s recommended dose, effectiveness and possible adverse effects, to mention a few.
Pre-clinical research is required before a medicine can be administered to humans since it can potentially create major health concerns. This is done to confirm the dose is proper and that there is no danger of toxicity. Pre-clinical research can include both in vitro and in vivo testing. For example, drug testing on animals may be performed at this stage before a drug is administered to people.
The clinical research stage of drug development starts when pre-clinical research is completed, and medicine is ready to be tested on people. The clinical study is the only method to be certain about how a person’s body will respond to medicine. Planning for clinical research can also be time-consuming, since it is necessary to determine how many individuals will participate; how long testing will continue; and what types of evaluations will be performed during this stage. Everything done throughout the clinical research stage must also adhere to FDA guidelines.
The developer can submit their study to the FDA once pre-clinical and clinical research has proved that medicine is safe and effective. Of course, receiving FDA approval for a new medicine is critical to put it on the market; thus, the FDA review is a crucial element of the drug development process. A developer must submit a New Drug Application (NDA) with complete information about their drug for their medication to be considered. This application incorporates all of the developer’s previous stage discoveries. The FDA has 6 to 10 months to finish the review. The FDA may have more concerns or request extra research before approving a new medicine.
Even after a medicine is approved, the FDA will continue to monitor its safety. To guarantee that the medicine is safe on the market, they monitor how the drug is promoted and any problems that develop. If there are medical issues, the FDA may intervene.
Effective Pharmaceutical Development
It’s clear that so much effort goes into producing new pharmaceuticals. Rondaxe can assist you during this procedure. Our development services are designed to benefit you from beginning to end. We understand how complicated pharmaceutical development is, which is why we provide everything you need, so that you can depend on us throughout the process. We have assisted in the approval of several medications through our services.
Contact us in New York at (315) 469-2800 or visit rondaxe.com online to learn more about how we can assist with drug development.