How Does Drug Development Work? 6 Key Steps

Have you ever wondered how the medicine you take for an illness or disease is developed? It’s a fascinating process that involves many stages, from identifying potential drug targets to gaining regulatory approval.

The journey of a drug from conception to market is a long and complex one that can take over a decade and cost billions of dollars. However, the result can make a huge difference in people’s lives by offering new treatments for diseases or improving existing ones.

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In this article, we’ll take you through the steps of drug development and give you insight into how it all works. So let’s dive into the world of drug development and learn about the key stages of bringing a new medicine to patients who need it.

#1 Discovery and Target Identification

The first step in drug development is identifying the target for treatment, which involves a complex process of researching and analysing potential drug targets. This process begins with scientists investigating the underlying mechanisms of a disease or condition to understand its root cause.

Scientists often use a professional medical research company such as Clarivate to help them research. These companies have access to thousands of databases and peer-reviewed records, which can help them source useful, reliable information. 

Once they’ve identified a potential target, such as a specific protein or enzyme involved in the disease process, they begin screening compounds that might interact with that target. This screening process typically involves testing thousands of compounds to identify those that show promise in binding to and modulating the activity of the target.

Once promising compounds are identified, they undergo further testing and optimisation to improve their effectiveness and safety. 

#2 Preclinical Research

First, you need to conduct preclinical research to test the safety and effectiveness of potential drug candidates before they can be tested on humans.

Preclinical research involves testing the drug candidate on animals like rats or mice to determine its toxicity, pharmacokinetics, and efficacy. This stage also involves identifying any potential side effects that may arise when the drug is used.

During preclinical research, scientists study how a drug candidate interacts with living organisms by conducting experiments in vitro (in a lab dish) or in vivo (in live animals). The results of these tests help researchers determine if the drug has the desired effect and how it affects different parts of the body.


If successful, preclinical research provides valuable information for designing clinical trials, eventually leading to FDA approval of a new medication.


#3 Investigational New Drug (IND) Application


Before beginning clinical trials, you must submit an Investigational New Drug (IND) application to your country’s FDA or relevant governing body. This application requests permission to conduct human clinical trials on your drug candidate.


The IND must include information about the drug’s chemical composition, manufacturing process, safety data from animal studies, and protocols for proposed clinical trials. The FDA reviews the IND within 30 days of submission to determine whether the proposed clinical trials are safe for humans.


#4 Clinical Trials


Once you’ve received approval for your IND application, you can begin conducting clinical trials to test the safety and efficacy of your drug candidate on human patients. Clinical trials are typically divided into three phases:

  • Phase 1 involves testing the drug on a small group of healthy volunteers to determine its safety and dosage.
  • Phase 2 involves testing the drug on a larger group of patients with its intended condition to treat to gather more information about its safety and effectiveness.
  • Phase 3 involves testing the drug on a larger group of patients in a randomised, double-blind study to confirm its safety and efficacy.


During each phase, researchers closely monitor participants for adverse reactions or side effects from the drug. They also collect data on how well the drug works compared to existing treatments or placebos.


The results of these trials are then submitted to regulatory agencies such as the FDA for review and approval before the drug can be made available for public use. 


Overall, clinical trials play a crucial role in ensuring that new drugs are safe and effective before they’re brought to market.


#5 New Drug Application (NDA) Submission


Now that you’ve completed the clinical trials, it’s time for you to submit your New Drug Application (NDA) to the regulatory agency for review and approval. This is a crucial step in drug development as it determines whether or not your drug can be marketed and sold to the public.


The NDA includes all the data from preclinical studies and clinical trials and information about the manufacturing process, labelling, and proposed use of the drug. The regulatory agency reviews the NDA thoroughly to ensure that the drug is safe and effective for its intended use.


They will assess all aspects of the application and may request additional information or clarification before deciding. Approval of an NDA can take several months or even years, depending on various factors such as the complexity of data, safety concerns, or demand for new treatments in that therapeutic area.


Receiving approval means your hard work has paid off, and patients will soon have access to a potentially life-saving treatment option.


#6 Approval and Post-Marketing


After receiving approval for your NDA, it’s important to continue monitoring the drug’s safety and effectiveness through post-marketing studies. 

These studies involve collecting data on how the drug is being used in the real world and any potential side effects or adverse events that may occur. 


To ensure the safety of patients, post-marketing studies include pharmacovigilance programs that track any new information about the drug’s safety profile. This can lead to changes in labelling or even a recall if necessary.

Post-marketing studies can also help identify new uses for the drug or improve its efficacy.

Continued monitoring after approval is crucial to ensuring a drug’s safety and effectiveness.

So, How Does Drug Development Work?

Drug development generally follows a process of research, clinical trials, approval and marketing. 

It’s important to note that drug development is a lengthy and costly process, with many hurdles along the way. However, each step is necessary to ensure the safety and effectiveness of new drugs before they are available on the market.

Drug development can take anything from a few years to decades. Without this rigorous process, patients could be at risk of harmful side effects or ineffective treatments. 

We hope this article has helped answer your question of ‘How does drug development work?’. Now that you have a better understanding of the processes, the next time you hear about a new drug hitting the market, remember all the hard work that went into its development!

Author Bio

George Luke is a professional Content writer and Content Marketer. Based in California, is an author and blogger with experience in encounter composing on various topics including but not limited to Home, Décor, Technology, Food, Marketing/Advertising, Lifestyle and beauty etc.

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