A nonclinical laboratory study refers to experiments conducted either in vivo (within a living organism) or in vitro (outside a living organism) to evaluate the safety of test articles. These studies are performed under controlled laboratory conditions and do not involve human subjects, clinical trials, or field trials involving animals. Additionally, they exclude basic exploratory studies aimed at assessing the potential utility or physical and chemical characteristics of a test article.
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This term is primarily used in the fields of pharmaceutical regulation, toxicology, and environmental science. Nonclinical laboratory studies are essential for ensuring that products, such as drugs and chemicals, are safe before they are tested in humans or released into the environment. Legal practitioners may encounter this term when dealing with regulatory compliance, product liability, or intellectual property related to safety testing. Users can manage relevant legal documents and forms through platforms like US Legal Forms, which provide templates created by experienced attorneys.
Key Legal Elements
Real-World Examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company conducts a nonclinical laboratory study to evaluate the toxicity of a new drug candidate in animal models before proceeding to human trials.
Example 2: A chemical manufacturer performs in vitro tests to assess the safety of a new compound intended for use in consumer products. (hypothetical example)
Relevant Laws & Statutes
The primary regulation governing nonclinical laboratory studies in the United States is outlined in Title 21 of the Code of Federal Regulations, specifically 21 CFR Part 58, which establishes Good Laboratory Practice (GLP) standards for these studies. These regulations ensure that the data generated from nonclinical studies are reliable and can be used for regulatory submissions.
Comparison with Related Terms
Term
Definition
Key Differences
Clinical Study
Research involving human subjects to assess the safety and effectiveness of a product.
Involves human participants, unlike nonclinical studies.
Field Trial
Testing conducted in a real-world environment, often involving animals or plants.
Conducted outside a laboratory setting, focusing on practical application.
Common Misunderstandings
What to Do If This Term Applies to You
If you are involved in developing a product that requires nonclinical laboratory studies, ensure compliance with relevant regulations, such as GLP standards. You may want to consult legal professionals to navigate regulatory requirements effectively. Additionally, consider using US Legal Forms to access templates for necessary documentation and forms related to nonclinical studies.
Quick Facts
Attribute
Details
Typical Fees
Varies based on the complexity of the study
Jurisdiction
Federal regulations apply, with state regulations varying
Possible Penalties
Non-compliance with GLP can lead to regulatory sanctions
Key Takeaways
FAQs
The purpose is to evaluate the safety of test articles before they are tested in humans or released into the environment.
In the U.S., the Food and Drug Administration (FDA) regulates these studies under the Good Laboratory Practice (GLP) standards.
No, nonclinical studies are specifically designed to exclude human subjects.
