Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Lesson objectives
3. Why the immune system?
4. Cornerstone of immunotoxicology
5. Possible consequences of immunomodulation
6. The immune system isn't confined to one site
7. T and B cell development
8. Average life span of blood cells
9. Innate vs. acquired immunity
10. Division of acquired immunity
11. The immune system can be targeted directly
12. The immune system can be targeted indirectly
13. Assessment of immunocompetence
14. Toxicology methods to assess immunocompetence
15. Suggested lymph nodes for histopathology
16. Non-functional assessment
17. Approaches to assessing immunotoxicity
18. Methods to assess immunocompetence (1)
19. Cell-mediated cytotoxicity
20. In vitro NK cell assay
21. Methods to assess immunocompetence (2)
22. Delayed-type hypersensitivity (DTH)
23. The DTH response
24. Local lymph node assay
25. Methods to assess immunocompetence (3)
26. T-dependent antibody response (TDAR) (1)
27. T-dependent antibody response (2)
28. Methods to assess immunocompetence (4)
29. Predictability of immune tests
30. Testing configurations
31. The immune system in regulatory toxicology testing
32. Regulatory immunotoxicology historical timeline (1)
33. Global regulatory considerations for new drugs
34. Overview of the 2002 FDA guidance
35. ICH S8: adverse (unintended) immunomodulation
36. ICH S8 objectives
37. ICH S8: recommended immunotoxicity evaluation
38. ICH S8: weight of evidence (WoE) review
39. Typical leukograms in animals / humans
40. A few words about stress
41. The WoE assessment should also include
42. Final factors to consider
43. Key points for data interpretation
44. Determination of a "cause for concern"
45. Cause for concern: immunotoxicity studies
46. ICH S8: immune evaluation consideration (1)
47. Regulatory immunotoxicology historical timeline (2)
48. Study designs for the rodent TDAR
49. Study designs for the NHP TDAR
50. General aspects of study designs (1)
51. General aspects of study designs (2)
52. ICH S8: immune evaluation consideration (2)
53. Models for host resistance
54. Host resistance assays
55. Consider additional immunotoxicity testing
56. Possible diagnostic and/or functional follow-up (1)
57. Possible diagnostic and/or functional follow-up (2)
58. Immune-mediated disease
59. What is immune-mediated disease?
60. Adverse drug reactions
61. Type 1 hypersensitivity
62. Type 2 hypersensitivity
63. Type 3 hypersensitivity
64. Autoimmunity / autoimmune disease
65. Drug-induced autoimmunity
66. Theories of drug-induced autoimmunity (1)
67. Theories of drug-induced autoimmunity (2)
68. Are there predictive models for autoimmunity?
69. Risk evaluation
70. What does It mean to humans?
71. Risk assessment in immunotoxicology
72. Challenges in assessing risk (1)
73. The "at risk" population
74. Challenges in assessing risk (2)
75. What is adverse?
76. How do we deal with the uncertainties?
77. Acknowledgments
78. 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:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Clinical Practice
• Immunology
• Pharmaceutical Sciences

Therapeutic Areas:

• Immunology & Inflammation

Talk Citation

Publication History

• Published on August 22, 2011

Financial Disclosures

• Dr. Leigh Ann Burns Naas has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.