Preclinical Vs. Nonclinical Studies: A Guide for Regulatory Affairs Students

If you’re studying regulatory affairs, you’ve probably already encountered a host of industry-specific terms used to denote different pharmaceutical practices, processes, compliances, measures, devices and more. Within the industry, agreed-upon definitions are developed in order to keep communication aligned and reduce misinterpretations. Upon entering a career in regulatory affairs, maintaining familiarity with common terms will not only help you to avoid confusion but to ensure the safe and lawful operation of the pharmaceutical organization you’re working with. 

In the field of pharmaceutical development and regulatory affairs, there are some terms that are frequently conflated. While often used interchangeably in the pharmaceutical development world, the terms preclinical and nonclinical studies can denote different things. By understanding which term should be used and when, you can enhance the soundness of drug development processes throughout your regulatory affairs career. Below, learn more about the difference between preclinical and nonclinical studies.

Definitions of Preclinical and Nonclinical Studies

Given the tendency to use the terms preclinical and nonclinical synonymously, perceiving the difference between them can be tricky once you enter the pharmaceutical regulatory affairs industry. In order to appreciate the distinction between the two types of studies, it’s easiest to start with their original definitions. Preclinical can be defined as:

• A study that occurs before clinical testing begins.

On the other hand, nonclinical is defined as:

• Studies that don’t involve the treatment and/or monitoring of patients who are living

While their actual definitions imply a significant difference, putting them into use requires an exploration of further questions which could challenge their distinguishing factors.

Nonclinical studies don’t involve human participants

Contexts in Which the Terms Are Used

For a more complete understanding of the difference between preclinical and nonclinical trials, it’s important to take a look at the kinds of contexts in which they might be used. Their exact definitions raise questions about the kinds of studies that fall under these broad categories. For example:

• Are basic laboratory studies included in either?
• Are in vitro or in vivo studies included in either?

The contexts in which the terms are used often depend on the type of pharmaceutical company or regulatory agency adopting them. For example, the United States Food and Drug Administration (FDA) uses a more specific definition of nonclinical studies, clarifying that this refers to in vitro or in vivo experiments used to determine the safety of test articles.

During your regulatory affairs career, you’ll often see pharmaceutical companies refer to their phase of development as “preclinical” before the compounds have been tested on humans. Additionally, service providers often use “nonclinical” as a descriptor of their animal labs, implying both types of studies are used before human testing.

As a regulatory affairs professional, you’ll notice that preclinical testing occurs before products are tested on humans

In Regulatory Affairs? Here’s What the Difference Comes Down To

Once you launch your career in regulatory affairs, you may be observing nonclinical or preclinical studies in order to ensure compliance and verify that the next step of the drug development process can begin. Now that we’ve covered the specific definitions and contexts within which the terms might be used, you can use these basic rules to differentiate between the two types of studies:

• Nonclinical laboratory studies can be referred to as preclinical if they are conducted right before the initial human clinical studies

Despite this slight difference, each study is designed to provide toxicity or safety information in the development of pharmaceutical products, often determining the amount of residual drug product.

Each study determines the safety of a pharmaceutical product

As you enter the regulatory affairs industry, you can use your knowledge of nonclinical or preclinical studies to improve the validity of your work. Using the right term will help to create a more accurate and streamlined development process, enhancing the safety of the end product.

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