Dermal Absorption and Toxicity: Concepts for …...Today’s Colloquium-Dermal Absorption and...
Transcript of Dermal Absorption and Toxicity: Concepts for …...Today’s Colloquium-Dermal Absorption and...
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Dermal Absorption and Toxicity: Concepts for Application to Safety
Assessment December 12, 2019
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Welcome, Overview, and Speaker Introductions
Jeffrey Yourick, PhD
Division of ToxicologyOffice of Applied Research and Safety Assessment
Center for Food Safety and Applied NutritionUS Food and Drug Administration
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Welcome, Overview, and Speaker Introductions
Society of Toxicology and US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series.
Provide high-quality, cutting-edge, future-oriented toxicological science
Provide well-grounded foundation to inform the work of US FDA employees.
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Welcome, Overview, and Speaker Introductions
These colloquia are open to the public to attend in person or via webcast.
These colloquia are not a public forum for discussion of toxicology regulatory issues.
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On-Site - Non FDA Employee
Webcast - FDA Employee
Webcast - Non FDA Employee
SOT FDA Colloquium Attendance (all 5 years)
Meeting Average 60 On-site
282 Webcast336 Total
Total onsite participation for the series is 960 and webcast attendance 4,618
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Colloquium Material Page Views
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16,000Rodent BioassayFood AllergyMetabolomicsMixturesIVIV ConcordanceFood PackagingAdversityIVIVEDev NeurotoxChildrenCramerMOAComputationalRisk AssessmentImmunotoxADME/PKPHOs
2015 20192016 20182017
Total of 309,808 page views
Average of 19,363 views per colloquium
Average of 76 video playbacks per colloquium
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2018-2019 Webcast Registration by Country
34 CountriesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaDenmarkFinlandFranceGermanyGreat Britain/UKHong KongIndiaItalyJapanLibyaMacedoniaMexicoMongoliaNetherlandsNorwayPakistan
PolandSaudi ArabiaSingaporeSouth KoreaSpainSwitzerlandTaiwanThailandTurkeyUnited StatesVirgin Islands
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FDA’s Predictive Toxicology Roadmap
https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap
Roadmap Goals:
• Foster the development and evaluation of emerging toxicological methods and new technologies
• Incorporate these methods and technologies into regulatory review, as applicable.
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Division of Toxicology – CFSAN/Office of Applied Research and Safety Assessment (OARSA)
Key Research Initiatives:
• Stem cell models for tox testing• Dermal and buccal absorption• In vitro renal and gastrointestinal models• Liver organ chip -hepatotoxcity• Bioprinting• In silico models for tox testing• Alternative animal models
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Today’s Colloquium-Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment Dermal absorption information is needed to conduct a realistic
exposure assessment for a chemical that contacts skin. Safety evaluation begins with an estimate of dermal human exposure. Dermal exposure is a function of:
– the amount of chemical applied to the skin– the duration of skin contact – area of body contact – chemical physio-chemical properties– extent of dermal absorption.
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Today’s Colloquium-Dermal Absorption and Toxicity: Concepts for Application to Safety Assessment, cont.
This colloquium will explore how different factors can affect the extent of dermal absorption.
A reasonable dermal estimate of human exposure can be calculated if the extent of skin absorption is realistically determined.
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SOT- Dermal Toxicology Specialty Section
Dermal Toxicology Specialty Section (DTSS) Mission – DTSS provides a forum for the interaction of individuals
involved in risk assessment, pharmacokinetics, dermal penetration/ absorption, hypersensitivity and dermal toxicity, regulatory issues, basic skin biology, and other professionals working in the field of dermal research.
More information on DTSS:https://www.toxicology.org/groups/ss/DTSS/mission.asp
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Welcome
Nancy Monteiro-Riviere, PhDColloquium Chair
Enjoy the Colloquium!
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SOT FDA Organizing Committee