Preclinical Toxicology & Safety and its core elements

Preclinical toxicology and safety occupies a position of eminence in a clinical research program. A study of preclinical toxicology and safety is absolutely important because this leads researchers to an understanding of what causes adverse effects. Adverse effects form the backbone of preclinical toxicology and safety, because they can come from any source of toxicology.

Toxicology, which is the study of adverse effects, can happen from any source ranging from chemicals to biological agents, as well as physical, or the environment.

So, preclinical toxicology and safety has to take safety into consideration both before the dose is administered in humans, and before clinical trials.

Good Laboratory Practices (GLPs) relating to preclinical toxicology and safety

A Good Laboratory Practice that relates to preclinical toxicology and safety is one that lists out regulations and practices that ensure data integrity from nonclinical studies. Since these are practices and conventions that have evolved over time; there are different GLPs prescribed by different regulatory bodies such as the FDA, the Organization for Economic Co-operation and Development (OECD) and the Environmental Protection Agency (EPA).

In the US, the FDA prescribes preclinical toxicology and safety GLPs under 21 CFR Part 58. At its simplest, 21 CFR Part 58 requires preclinical studies to be compliant with GLP relating to:

• In vitro toxicology
• In vivo toxicology
• Animal models

Very broadly, preclinical toxicology and safety requirements for each of these types of toxicology can be understood thus:

• In vitro

Preclinical toxicology and safety relating to in vitro toxicology is used for screening and ranking chemicals and the study of cell and tissue. GLPs for in vitro preclinical toxicology and safety are centered on improving future study design/s.

• In vivo

The purpose of in vivo toxicology is to establish a starting dose for clinical studies that is safe.

So, GLPs for in vivo preclinical toxicology and safety are meant to offer information on a drug that spews the least toxicity.

• Animal studies

Finally, preclinical toxicology and safety in animal studies are assessed to serve treatment outcomes better in humans by testing drugs on animals. This is based on the assumption that these organisms serve as a proper indicator of how these drugs could act in humans.

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