• 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. Nervous systems evaluation
3. Looking at the right place
4. The brain is a heterogeneous tissue
5. General toxicology examination of the brain
6. Rules of thumb for sampling
7. Sectioning interval for 60 sections
8. Creating a sectioning scheme
9. Trimming scheme
10. The use of the trimming method
11. Trimming scheme - dog brain
12. Trimming scheme - rodent brain
13. The spinal cord
14. Looking at the right times
15. Each compound has its own cell death peak
16. Rat brain treated with MK801 (1)
17. Rat brain treated with MK801 (2)
18. The role of imaging in toxicology studies
19. Looking in the right way
20. Tissue changes are not created equal
21. Perfusion fixation
22. Neuronal necrosis stains
23. Cupric silver stain
24. Fluoro Jade B stain
25. IBA-1 stain
26. GFAP stain
27. Luxol fast blue vs. classic silver stain
28. Special procedures example
29. Comparison of embedding and staining techniques
30. Examples of high quality samples
31. Longitudinal nerve sections (1)
32. Longitudinal nerve sections (2)
33. Electron micrograph
34. Summary
35. Thank you and acknowledgements

Topics Covered

• Brain is a heterogeneous tissue: you must look at many sections
• Different toxicants affect different areas
• Timing is important but most cell death occurs early (1 to 4 days)
• Appropriate fixation is crucial
• Appropriate staining methods are necessary to detect changes in various cell types (neurons, glial cells)

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Neuroscience
• Pharmaceutical Sciences

Therapeutic Areas:

• Neurology

Talk Citation

Publication History

• Published on July 30, 2009
• Archived on February 25, 2021

Financial Disclosures

• Dr. Mark Butt has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.