Good Laboratory Practices (GLPs)

Nonclinical laboratory studies are one of the first steps taken in bringing a new drug, device, or biologic to the marketplace so it is important that practices are in place to ensure the reliability of the study and the safety and efficacy of the product. This lesson is intended to give the learner an introduction to Good Laboratory Practice Regulations (GLP) and their application to nonclinical animal safety and toxicology studies. This lesson should provide the learner with an understanding of terminology and acceptable practices for nonclinical laboratory studies and the role Good Laboratory Practices play in assuring the validity of these studies.