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- Introduction
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2. Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
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3. Biological safety testing: supporting medical device combination products
- Dr. Christine L. Lanning
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4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH
- Dr. John Kapeghian
- Basics of Non-clinical Toxicity Testing
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6. Acute, subchronic, and chronic toxicity testing
- Mr. Gregory Ruppert
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7. Safety pharmacology in human pharmaceutical development
- Dr. R. Dusty Sarazan
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8. Genetic toxicology
- Dr. Roderick Todd Bunch
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9. Reproductive and developmental toxicology
- Dr. Alan Hoberman
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10. Juvenile toxicity testing
- Dr. Alan Hoberman
- Dr. Elise Lewis
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11. Pharmacokinetics, toxicokinetics and safety margins
- Dr. Mark Rogge
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12. Toxicity testing of impurities and metabolites
- Dr. Kurt Black
- Organ System Toxicity Testing
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13. Drug induced liver injury: a clinical perspective
- Prof. Victor Navarro
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14. Toxicology of the kidney
- Prof. Lawrence Lash
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15. Toxicology of the cardiovascular system
- Dr. Peter Siegl
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16. Toxicology of the immune system
- Dr. Leigh Ann Burns Naas
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17. Toxicology of the developing immune system
- Dr. Leigh Ann Burns Naas
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18. Hematology interpretation for toxicity studies
- Dr. Nancy Everds
- New Methods for Assessing Toxicity
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19. Introduction to toxicogenomics and example case studies
- Dr. Cindy Afshari
- Special Cases for Toxicity Testing
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21. Approaches to nonclinical vaccine development
- Dr. Lisa Plitnick
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22. Toxicity testing of oncology drugs: unraveling the last 15 years of progress
- Dr. Krishna Allamneni
- Archived Lectures *These may not cover the latest advances in the field
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23. Cellular and molecular toxicology
- Dr. Dominic Williams
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24. Overview of non-clinical safety assessment in drug development
- Dr. Danuta Herzyk
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27. Reproductive and developmental toxicology
- Dr. Alan Hoberman
- Dr. Elise Lewis
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28. Non-clinical toxicity testing for vaccines
- Dr. Lisa Plitnick
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29. Toxicity testing for oncology drugs
- Dr. Theresa Reynolds
- Dr. Krishna Allamneni
Printable Handouts
Navigable Slide Index
- Introduction
- Objectives
- Historical perspective
- The developing immune system (1)
- The developing immune system (1)
- Why might kids be different?
- Qualitative difference
- Quantitative difference
- Temporal difference
- Global regulatory drivers and need for DIT testing
- The concept of critical windows of development
- A part of the Hematopoietic System
- Critical windows of vulnerability (1)
- Critical windows of vulnerability (2)
- Critical windows of vulnerability (3)
- Critical windows of development
- Comparative immune system development
- Rodent vs. human immune system
- Non-human primate vs. human immune system
- What's the evidence for a differential sensitivity
- Differential sensitivity - lead
- Differential sensitivity - TBTO
- Evidence for differential sensitivity
- Putative impact of xenobiotics
- Dosing paradigms in historical DIT studies
- What we know
- Implications for immunotoxicity testing
- In the context of human risk...
- Assessing developmental immunotoxicity
- The T-dependent antibody response (TDAR)
- Splenic lymphocyte populations 10-day old rats
- Splenic lymphocyte populations 21-day old rats
- Functional assessment - humoral (1)
- Functional assessment - humoral (2)
- Functional assessment - cellular
- Immunotoxicity across the developmental timeline
- The word on immunopathology in rat
- Other assessment possibilities
- Study designs to assess DIT
- Factors to consider in study design (1)
- Factors to consider in study design (2)
- Factors to consider in study design (3)
- Stand-alone DIT study
- Extended 1-generation reproductive toxicity study
- Add-on to rat peri- and postnatal development
- DIT in the nonhuman primate
- Human health implications
- Translational research
- Risk assessment - what can we say?
- Knowledge gaps and limitations
- Acknowledgments
- References
Topics Covered
- Historical background, regulatory and scientific
- Immune development across species
- Critical windows of immune system development
- Evidence for possible differential sensitivity -Methods to assess developmental immunotoxicity -Representative study designs -Risk evaluation
- Knowledge and data gaps
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Burns Naas, L.A. (2012, September 9). Toxicology of the developing immune system [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/VRGT3800.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Leigh Ann Burns Naas has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.