• Introduction
• 29 min
  1. General introduction to non-clinical toxicity testing of pharmaceuticals

  • Dr. Andrea Weir
• 14 min
  2. Overview of nonclinical safety assessment

  • Dr. Claudette L. Fuller
• 12 min
  3. Biological safety testing: supporting medical device combination products

  • Dr. Christine L. Lanning
• 34 min
  4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH

  • Dr. John Kapeghian
• 48 min
  5. Toxicology testing standards: good laboratory practices and the institutional animal care committee

  • Dr. Peter Thomas
• Basics of Non-clinical Toxicity Testing
• 20 min
  6. Acute, subchronic, and chronic toxicity testing

  • Mr. Gregory Ruppert
• 56 min
  7. Safety pharmacology in human pharmaceutical development

  • Dr. R. Dusty Sarazan
• 42 min
  8. Genetic toxicology

  • Dr. Roderick Todd Bunch
• 48 min
  9. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
• 48 min
  10. Juvenile toxicity testing

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 43 min
  11. Pharmacokinetics, toxicokinetics and safety margins

  • Dr. Mark Rogge
• 48 min
  12. Toxicity testing of impurities and metabolites

  • Dr. Kurt Black
• Organ System Toxicity Testing
• 38 min
  13. Drug induced liver injury: a clinical perspective

  • Prof. Victor Navarro
• 62 min
  14. Toxicology of the kidney

  • Prof. Lawrence Lash
• 58 min
  15. Toxicology of the cardiovascular system

  • Dr. Peter Siegl
• 67 min
  16. Toxicology of the immune system

  • Dr. Leigh Ann Burns Naas
• 59 min
  17. Toxicology of the developing immune system

  • Dr. Leigh Ann Burns Naas
• 43 min
  18. Hematology interpretation for toxicity studies

  • Dr. Nancy Everds
• New Methods for Assessing Toxicity
• 45 min
  19. Introduction to toxicogenomics and example case studies

  • Dr. Cindy Afshari
• Special Cases for Toxicity Testing
• 46 min
  20. Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials

  • Dr. Joy Cavagnaro
• 32 min
  21. Approaches to nonclinical vaccine development

  • Dr. Lisa Plitnick
• 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
• 56 min
  23. Cellular and molecular toxicology

  • Dr. Dominic Williams
• 31 min
  24. Overview of non-clinical safety assessment in drug development

  • Dr. Danuta Herzyk
• 42 min
  25. Evaluation of the adult nervous system in preclinical studies

  • Dr. Mark Butt
• 56 min
  26. Non-clinical development of pharmaceuticals using engineered animal models

  • Dr. Brad Bolon
• 22 min
  27. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 13 min
  28. Non-clinical toxicity testing for vaccines

  • Dr. Lisa Plitnick
• 36 min
  29. Toxicity testing for oncology drugs

  • Dr. Theresa Reynolds
  • Dr. Krishna Allamneni

Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Objectives
3. Historical perspective
4. The developing immune system (1)
5. The developing immune system (1)
6. Why might kids be different?
7. Qualitative difference
8. Quantitative difference
9. Temporal difference
10. Global regulatory drivers and need for DIT testing
11. The concept of critical windows of development
12. A part of the Hematopoietic System
13. Critical windows of vulnerability (1)
14. Critical windows of vulnerability (2)
15. Critical windows of vulnerability (3)
16. Critical windows of development
17. Comparative immune system development
18. Rodent vs. human immune system
19. Non-human primate vs. human immune system
20. What's the evidence for a differential sensitivity
21. Differential sensitivity - lead
22. Differential sensitivity - TBTO
23. Evidence for differential sensitivity
24. Putative impact of xenobiotics
25. Dosing paradigms in historical DIT studies
26. What we know
27. Implications for immunotoxicity testing
28. In the context of human risk...
29. Assessing developmental immunotoxicity
30. The T-dependent antibody response (TDAR)
31. Splenic lymphocyte populations 10-day old rats
32. Splenic lymphocyte populations 21-day old rats
33. Functional assessment - humoral (1)
34. Functional assessment - humoral (2)
35. Functional assessment - cellular
36. Immunotoxicity across the developmental timeline
37. The word on immunopathology in rat
38. Other assessment possibilities
39. Study designs to assess DIT
40. Factors to consider in study design (1)
41. Factors to consider in study design (2)
42. Factors to consider in study design (3)
43. Stand-alone DIT study
44. Extended 1-generation reproductive toxicity study
45. Add-on to rat peri- and postnatal development
46. DIT in the nonhuman primate
47. Human health implications
48. Translational research
49. Risk assessment - what can we say?
50. Knowledge gaps and limitations
51. Acknowledgments
52. 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:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Immunology
• Pharmaceutical Sciences

Therapeutic Areas:

• Immunology & Inflammation

Talk Citation

Publication History

• Published on September 9, 2012

Financial Disclosures

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