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- Introduction
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29 min
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14 min
2. Overview of nonclinical safety assessment- Dr. Claudette L. Fuller
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12 min
3. Biological safety testing: supporting medical device combination products- Dr. Christine L. Lanning
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34 min
4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH- Dr. John Kapeghian
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48 min
- Basics of Non-clinical Toxicity Testing
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20 min
6. Acute, subchronic, and chronic toxicity testing- Mr. Gregory Ruppert
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56 min
7. Safety pharmacology in human pharmaceutical development- Dr. R. Dusty Sarazan
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42 min
8. Genetic toxicology- Dr. Roderick Todd Bunch
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48 min
9. Reproductive and developmental toxicology- Dr. Alan Hoberman
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48 min
10. Juvenile toxicity testing- Dr. Alan Hoberman
- Dr. Elise Lewis
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43 min
11. Pharmacokinetics, toxicokinetics and safety margins- Dr. Mark Rogge
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48 min
12. Toxicity testing of impurities and metabolites- Dr. Kurt Black
- Organ System Toxicity Testing
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38 min
13. Drug induced liver injury: a clinical perspective- Prof. Victor Navarro
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62 min
14. Toxicology of the kidney- Prof. Lawrence Lash
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58 min
15. Toxicology of the cardiovascular system- Dr. Peter Siegl
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67 min
16. Toxicology of the immune system- Dr. Leigh Ann Burns Naas
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59 min
17. Toxicology of the developing immune system- Dr. Leigh Ann Burns Naas
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43 min
18. Hematology interpretation for toxicity studies- Dr. Nancy Everds
- New Methods for Assessing Toxicity
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45 min
19. Introduction to toxicogenomics and example case studies- Dr. Cindy Afshari
- Special Cases for Toxicity Testing
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46 min
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32 min
21. Approaches to nonclinical vaccine development- Dr. Lisa Plitnick
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54 min
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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56 min
23. Cellular and molecular toxicology- Dr. Dominic Williams
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31 min
24. Overview of non-clinical safety assessment in drug development- Dr. Danuta Herzyk
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42 min
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56 min
-
22 min
27. Reproductive and developmental toxicology- Dr. Alan Hoberman
- Dr. Elise Lewis
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13 min
28. Non-clinical toxicity testing for vaccines- Dr. Lisa Plitnick
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36 min
29. Toxicity testing for oncology drugs- Dr. Theresa Reynolds
- Dr. Krishna Allamneni
Printable Handouts
Navigable Slide Index
- Introduction
- Lesson objectives
- Why the immune system?
- Cornerstone of immunotoxicology
- Possible consequences of immunomodulation
- The immune system isn't confined to one site
- T and B cell development
- Average life span of blood cells
- Innate vs. acquired immunity
- Division of acquired immunity
- The immune system can be targeted directly
- The immune system can be targeted indirectly
- Assessment of immunocompetence
- Toxicology methods to assess immunocompetence
- Suggested lymph nodes for histopathology
- Non-functional assessment
- Approaches to assessing immunotoxicity
- Methods to assess immunocompetence (1)
- Cell-mediated cytotoxicity
- In vitro NK cell assay
- Methods to assess immunocompetence (2)
- Delayed-type hypersensitivity (DTH)
- The DTH response
- Local lymph node assay
- Methods to assess immunocompetence (3)
- T-dependent antibody response (TDAR) (1)
- T-dependent antibody response (2)
- Methods to assess immunocompetence (4)
- Predictability of immune tests
- Testing configurations
- The immune system in regulatory toxicology testing
- Regulatory immunotoxicology historical timeline (1)
- Global regulatory considerations for new drugs
- Overview of the 2002 FDA guidance
- ICH S8: adverse (unintended) immunomodulation
- ICH S8 objectives
- ICH S8: recommended immunotoxicity evaluation
- ICH S8: weight of evidence (WoE) review
- Typical leukograms in animals / humans
- A few words about stress
- The WoE assessment should also include
- Final factors to consider
- Key points for data interpretation
- Determination of a "cause for concern"
- Cause for concern: immunotoxicity studies
- ICH S8: immune evaluation consideration (1)
- Regulatory immunotoxicology historical timeline (2)
- Study designs for the rodent TDAR
- Study designs for the NHP TDAR
- General aspects of study designs (1)
- General aspects of study designs (2)
- ICH S8: immune evaluation consideration (2)
- Models for host resistance
- Host resistance assays
- Consider additional immunotoxicity testing
- Possible diagnostic and/or functional follow-up (1)
- Possible diagnostic and/or functional follow-up (2)
- Immune-mediated disease
- What is immune-mediated disease?
- Adverse drug reactions
- Type 1 hypersensitivity
- Type 2 hypersensitivity
- Type 3 hypersensitivity
- Autoimmunity / autoimmune disease
- Drug-induced autoimmunity
- Theories of drug-induced autoimmunity (1)
- Theories of drug-induced autoimmunity (2)
- Are there predictive models for autoimmunity?
- Risk evaluation
- What does It mean to humans?
- Risk assessment in immunotoxicology
- Challenges in assessing risk (1)
- The "at risk" population
- Challenges in assessing risk (2)
- What is adverse?
- How do we deal with the uncertainties?
- Acknowledgments
- References
Topics Covered
- Introduction to the Immune System
- Assessment of Immunocompetence
- The Immune System in Regulatory Toxicology Testing, including ICH S8: Adverse (Unintended) Immunomodulation
- Immune-Mediated Disease
- Risk Evaluation
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Burns Naas, L.A. (2011, August 22). Toxicology of the immune system [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/MRKN9297.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.
Toxicology of the immune system
Published on August 22, 2011
67 min
