NeuAge Institute (NAI)

In Pharmacovigilance Courses? Why We Need Preclinical Studies

The development of a new drug, from concept to approval, follows well established paths created and monitored by the U.S. Food and Drug Administration (FDA). The FDA’s Drug Development process consists of 5 steps: Discovery, Preclinical Studies, Clinical Studies, FDA Review, and FDA Post-Market Safety Monitoring. These steps were created to ensure that new drugs are safe and effective for public use.

There are many regulatory actions taken throughout the drug development stages to monitor and prevent adverse effects and other medicine related issues before and after a drug is approved for the public. If you are considering a career in pharmacovigilance, it is vital to understand the role that preclinical studies play in drug development and how they support the safety, ethics, and validity of clinical studies. 

At NeuAge Institute, our Drug Development, Clinical Research, Drug Safety and Pharmacovigilance Certification prepares students with a comprehensive education on topics such as Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP), amongst other important aspects to ensuring the safety and effectiveness of pharmaceutical products through the different stages of drug development. 

Keep reading to learn more about preclinical studies and the role pharmacovigilance plays in this important step of drug development. 

There are Two Different Types of Preclinical Studies

During your pharmacovigilance courses, you will learn about the many different methods within the drug development process, and the corresponding rules and regulations that exist for each. 

Latin for “in glass”, in vitro preclinical studies occur outside of a living organism, as live cells are removed and tested in a controlled or artificial environment, such as a petri dish or test tube. There are many benefits to in vitro preclinical trials, the first being the lack of harm done to the animal or person the cell cultures are taken from. In addition, in vitro studies are much more affordable than their counterpart, and are viewed as being efficient and reliable. Conversely, the major shortcoming of in vitro studies is the inability to view or model how a drug may interact with the rest of the body. 

Latin for “within the living”, in vivo preclinical studies are done on a whole living organism, namely lab animals. This allows researchers to view the impact of a new drug on the whole body, rather than isolated cells. Although this addresses the shortcomings seen with in vitro studies, in vivo studies have their own drawbacks. The largest issue faced is the ethical concerns for the animals used for testing. The laws around animal testing are tightening regarding preclinical in vivo testing, forcing scientists to demonstrate that alternative modes of testing would not suffice.  Consequently, the rules and regulations for Good Laboratory Practices (GLP) are much more strict when it comes to in vivo use, as seen in the FDA’s Code of Regulations Title 21

Regardless of the method chosen, pharmacovigilance plays an important role in ensuring that preclinical studies are conducted according to the rules and guidelines administered by governing authorities like the FDA. Only the drugs that are proven to be safe and effective move forward to the next stage of drug development.

You’ll learn about the different methods and regulations of the drug development process during your pharmacovigilance courses.

Understanding the Difference Between Preclinical and Clinical Studies

As its name suggests, preclinical studies occur before clinical studies. During preclinical studies, whether it be in vitro or in vivo, testing can only be done on isolated cells or on animals. Extensive tests and studies lead to preliminary information about the efficacy, safety, and validity of a new drug. With detailed information on toxicity levels and dosing, it can then be evaluated if the drug should move forward to the clinical phase and be tested on people. Thus, the biggest difference between the two stages of drug development is that a new drug cannot be tested on people during the preclinical phase. It is only once a drug is approved to move forward to clinical studies that it can be tested on humans. 

Your role will be to protect public safety after your pharmacovigilance certification by ensuring the rules and regulations of drug development are followed.

The Importance of Preclinical Studies After Your Pharmacovigilance Certification

Your pharmacovigilance and drug safety training will prepare you for roles in which you will be responsible for evaluating whether preclinical trials meet pharmacovigilance standards. Preclinical studies can only move forward to clinical studies if the findings are viewed as successful and meet these rules and regulations. Thus, preclinical trials not only support the safety, validity, and ethics of clinical studies, but also are an essential aspect of drug development and pharmacovigilance.

Our students benefit from a practical approach to learning, with access to a strong professional network. With monthly start dates and a self-pace online program, you can confidently start your new career in as little as 36 weeks.


Are you interested in obtaining your pharmacovigilance certification?

Contact NAI for more information today!




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