Philadelphia, PA - There’s more to the drug development process than most people know. Before a drug can be distributed and sold on the market, it must go through several stages of development to ensure that it’s safe, effective, and has passed all the regulatory requirements.
What to Know About The Drug Development Process
To start, this article will be discussing a list of things that you should know about the drug development process.
1 - Five Stages Of Development Process
In the US, the drug development process has five critical stages, which are as follows:
- Discovery and Development
The entire drug development process starts at the laboratory. This is where thousands of different compounds and chemicals are assessed, tested, and narrowed over time. The discovery process involves the screening of different chemical entities to identify which are safe to be used and which among them offer therapeutic capabilities.
Once researchers find an ideal drug candidate, the development phase can begin. During this phase, researchers conduct additional tests to determine vital information such as drug dosage, side effects, efficacy, how the proposed drug interacts with other medications and treatments, and many more.
- Preclinical Research
This part of the research process is done to determine the drug’s possible side effects or if it can cause serious health problems to people. These studies aim to provide researchers with more information about the recommended dosage and possible toxicity levels of the drug. This is also where the drug testing on animals is conducted before the medicine is given to humans.
- Clinical Research
Once preclinical studies are done, researchers can now move on to the most critical part of the drug development process- clinical research. This phase is where the drugs are finetuned for human use, which can take several years.
- Food And Drug Administration (FDA) Review
Once the results of the clinical research show that the proposed drug is deemed safe and effective for human use, the drug will then be submitted to the Food and Drug Administration (FDA) for further review and approval.
When filing for FDA review and approval, pharmaceutical companies can seek the help and assistance of third-party agencies that offer dataset validation.
The FDA reviews the drug for about a year before it can make a decision. Once the drug is approved, the pharmaceutical company can then gain the right to market its product to the public.
- Post-market Monitoring
Even if the drug is approved by the FDA and is already sold to the market, it is still subjected to the federal agency’s monitoring and evaluation. The agency continuously monitors the drug to ensure that it is safe and effective throughout its production run, including its long-term benefits, side effects (if there are any), and optimal dosage.
Moreover, the FDA also watches how the drug is sold and advertised. And if there are any problems or concerns that arise like a drug overdose, it is expected that they will step in.
2 - Timeline
The entire drug development process can be lengthy, tedious, and grueling. In fact, it may take years before a new drug can be developed and approved. The big reason for this is because the active ingredient in a drug has to go through different studies and layered testing, to ensure its safety and effectiveness.
And afterward, the proposed drug has to wait for the appropriate approval, which can also take several months or even years, from the respective governing bodies before it can be made available on the market.
3 - It Is Very Costly
Aside from the time, the drug development process also requires a hefty budget allocation for the research and development to push through. In other words, a pharmaceutical company will have to spend a lot of resources before putting a new drug on the market.
One of the reasons why the cost is so high is because pharmaceutical companies must take into account the additional costs, such as the cost of failed trials or drugs that are usually incurred during clinical trials. Moreover, the cost of developing drugs can also be higher if the medicine being developed is designed to treat chronic diseases such as cancer.
While a new drug can certainly influence and improve the medical industry, it’d be good to note that the entire process of developing a new drug can be complex. It requires a massive amount of time, resources, and finances. And since these medicinal innovations involve the health of the community, it is only important that they go through extensive research and testing to ensure that they are safe and effective for human consumption.