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Overview of nonclinical safety assessment
Published on September 30, 2020 14 min
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Welcome to the overview of nonclinical safety assessment. My name is Claudette Fuller of Merck & Company at West Point, Pennsylvania. If you're new to drug development, this talk is intended to be a primer of some of the basic concepts you'll encounter, as well as provide some useful resources.
I'll first define the role of nonclinical safety assessment in drug development. Next, I'll touch on the key organizations responsible for issuing guidance for drug development, as well as what some of those guidances are. Then I'll step through some important concepts in toxicology and the different types of assessments that make up a nonclinical toxicology program. I'll also discuss the types of studies needed for different stages of drug development and considerations for designing a nonclinical toxicology program. Last, I'll provide some useful resources such as links to various guidance documents and a list of related Henry Stewart talks, that go into more detail around some of the topics that I'll just touch upon here.
The goal of drug discovery organizations is to find an evaluate targets that are druggable and evaluate their efficacy in pre-clinical models. The objective of safety assessment is to aid in the selection of the drug candidate with the fewest safety liabilities. Safety assessment identifies potential hazards for humans,uid for a given target and then gathers data to help put the risks for that hazard into perspective for a given patient population. The data for risk assessment comes from the interpretation of thoughtfully designed in vitro and in vivo studies in well-characterized toxicology models. These data must then be presented in a straightforward, concise manner in regulatory documents to support the approval of first-in-human clinical trials and subsequent registration.