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Printable Handouts
Navigable Slide Index
- Introduction
- Presentation overview
- Overview of the FDA
- Role of the FDA in drug development
- Elixir of sulfanilamide
- The thalidomide tragedy
- Elixir of sulfanilamide and thalidomide baby
- Centers within the FDA
- Human medical products at FDA
- CDER divisions
- FDA/CDER scientific review team
- Pharmacology and toxicology at FDA/CDER
- Testing of new drugs for safety and efficacy
- Submissions to the FDA/CDER
- Drug development: the non-clinical perspective
- Non-clinical studies
- Drug development process
- Regulations and guidance
- Regulations website
- Examples of regulations
- Guidance documents
- The ICH process
- FDA/CDER guidance documents
- Non-clinical topics covered in ICH guidance
- Topics covered in the CDER non-clinical guidance
- Types of non-clinical studies
- Clinical trials
- Phase 1
- Phase 2
- Phase 3
- Non-clinical vs. clinical development
- Safety concerns identified in non-clinical studies
- Questions answered through non-clinical studies
- Safety concerns (1)
- Safety concerns (2)
- Safety concerns (3)
- Safety concerns (4)
- Addressing concerns from non-clinical studies
- Non-clinical data: supporting safety evaluation
- Laboratory animals vs. humans (1)
- Laboratory animals vs. humans (2)
- Laboratory animals vs. humans (3)
- Non-clinical vs. clinical toxicity
- The concordance publication
- Background for concordance publication
- Correlation of human and animal toxicities (1)
- Correlation of human and animal toxicities (2)
- Summary
- Acknowledgements
- References
Topics Covered
- Overview of the Food and Drug Administration (FDA)
- Role of the FDA in drug development
- Overview of drug development from a non-clinical perspective
- Non-clinical guidance documents and studies
- Clinical trials
- Using non-clinical data to support safe drug development
- Comparison of humans to animal models
- Correlation between clinical and non-clinical toxicities
Links
Series:
Categories:
Talk Citation
Weir, A. (2016, December 28). General introduction to non-clinical toxicity testing of pharmaceuticals [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 13, 2024, from https://doi.org/10.69645/UDQM9993.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Andrea Weir has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
General introduction to non-clinical toxicity testing of pharmaceuticals
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, I am Andrea Weir.
I'm a toxicologist by training,
and I've spent the majority
of my career in drug development.
I was a reviewer
of non-clinical pharmacology
and toxicology submissions
at the US Food and Drug Administration
from 1993 to 2005.
In 2005, I joined Charles River Laboratories
as part of a group
known as Navigator Services.
In that role, I provided scientific
and regulatory advice to clients
regarding their non-clinical
development programs.
In 2015, I joined ToxStrategies Incorporated
as a senior consultant
with the Biopharmaceutical/Pharmaceutical
Practice.
In this role, I assist clients
with managing the scientific
and regulatory challenges of their
non-clinical drug development programs.
0:53
During this presentation,
I will be providing an overview
of the Food and Drug Administration
and of drug development
from the non-clinical perspective.
I will be addressing potential
safety concerns
that could be identified
in non-clinical studies, as well as
considerations for using data
from non-clinical studies
to support safe drug development.
Finally, I'll be providing information
on the correlation between
non-clinical and clinical toxicities.
1:20
In the next several slides,
I will describe the different centers
within FDA and describe their function.
1:28
In the United States,
it is illegal to test new drugs in humans
or to market new drugs for human use
without having approval from the FDA.
FDA is responsible for ensuring
that clinical trials are safely conducted
and that safe and efficacious drugs
are approved for marketing.
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