• 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. Presentation outline
3. Toxicogenomics - what is it? (1)
4. Toxicogenomics - what is it? (2)
5. Toxicogenomics - what is it not?
6. Toxicogenomics - general considerations
7. Impact to screening and lead optimization
8. Compound discrimination: consider via dose
9. Discrimination for compounds/doses
10. Molecules discrimination requires reproducibility
11. Matched similarity of benchmark and compound
12. Correlation with "informative" signatures
13. Pathway analysis of increased genes
14. Pathway modeling
15. Modulation of the notch pathway
16. Change in notch pathway genes after treatment
17. Number of altered transcripts as an index
18. Value of overall detection of transcript changes
19. Understanding compound mechanism of action
20. Case study
21. 4-day rat studies: induced ALT and AST levels
22. Differential regulation across compounds
23. 28 gene signature correlates with toxicity
24. Clinical candidate indicated on ALT/AST chart
25. 28 gene signature of clinical candidate
26. Future candidate selection
27. For the future: translation
28. Conclusions
29. Acknowledgements

Topics Covered

• What is toxicogenomics and what is it not?
• General considerations
• Compound discrimination
• Pathway modeling
• Modulation of the notch pathway
• Altered transcripts
• Understand compound mechanism of action
• Case study: hepatotoxicity
• For the future: translation

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on August 9, 2009

Financial Disclosures

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