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Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Nonclinical safety assessment
- Key organisations
- ICH guidelines
- ICH multidisciplinary and quality guidelines
- ICH safety guidelines (1)
- ICH safety guidelines (2)
- ICH safety guidelines (3)
- EMA and FDA guidelines and regulations
- Toxicology (1)
- Toxicology (2)
- Scientific Disciplines in safety assessment (1)
- Scientific Disciplines in safety assessment (2)
- Toxicology studies required for clinical Trials
- Comparison of nonclinical drug programs
- points to consider in general toxicology studies
- Repeat dose toxicology studies - ICH M2(R2)
- Timing of studies for non-oncology indications
- Special considerations for advanced cancer indications
- General timing of studies - oncology
- Special considerations for advanced cancer
- Related Henry Stewart talks
- Relevant guidances and regulations
- Acknowledgements
Topics Covered
- Introduction to nonclinical safety assessment and toxicology
- Key organizations for drug development guidance
- Scientific specialties involved in safety assessment
- Comparisons of nonclinical drug development programs
- Non-oncology vs. oncology therapeutic areas
Links
Series:
Categories:
Talk Citation
Fuller, C.L. (2020, September 30). Overview of nonclinical safety assessment [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 11, 2024, from https://doi.org/10.69645/YHYM9330.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
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.
0:18
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.
0:58
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.