The Different Stages of Drug Development

Updated on July 20, 2022
The Different Stages of Drug Development

A drug trial is a lengthy and carefully studied process that requires putting a lot of hard work and effort into every step. When it comes to the different stages of drug development, there are five key phases to which scientists and doctors must rigidly adhere.

1. Discovery and Development

Discovery and development are the first stages of the laborious process. Scientists discover new information about diseases and analyze potential molecular compounds that may offer medical benefits. Discovery may also involve looking into utilization techniques of new technologies. When a particular compound warrants further investigation, they move on to development.

Development is the stage where doctors and scientists look at the practical applications of the compound to determine the best method of administration, potential dosage levels, evident side effects, and how it may interact with well-known drugs.

2. Preclinical Research

Preclinical research is one of the shorter stages of drug development as scientists attempt to test their new compound in a laboratory environment and look for any abnormalities or adverse effects. This step is an integral part of the process before attempting to test the drug on humans.

3. Clinical Development

Clinical development involves testing the drug on human subjects and is one of the most important steps in drug development. It is during these trials that unexpected effects may appear, such as noticing if other medications neutralize the compound or are potentially harmful to those with certain pre-existing conditions.

Scientists carefully seek test subjects that meet specific qualifications and use the data from this stage to ensure the medicine is safe and raise awareness of potentially harmful side effects.

4. FDA Review

After extensive clinical development and testing, companies may submit a New Drug Application to the FDA for a full review. The FDA reviews all of the information submitted by the company and moves forward to either file or reject the application.

Typically, the FDA review determines if a drug is safe for its intended purpose. It will then go through a labeling process to give accurate information regarding how to prescribe and distribute the medicine.

5. Post-Market Monitoring

Clinical trials and FDA reviews often create a detailed and well-informed report once the development process is completed. However, once a drug is on the market, it’s essential to analyze and monitor factors such as any differences between the original NDA and what’s on the market, the ways advertisers promote the medication, and general surveillance to see if any additional problems or concerns arise.

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