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.