• 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. Course objectives
3. The promise of engineered models
4. Why examine engineered mice?
5. Production and validation of engineered models
6. Types of engineered animals
7. Transgenic mice by microinjection
8. Knockout mice (gene targeting)
9. Utilization of gene targeting technology
10. Validation milestones for engineered models
11. Characterization of genetically engineered animals
12. Sample protocol for screening engineered animals
13. Standardizing genetic and environmental variables
14. Selecting the most appropriate engineered model
15. Approaches to functional genomics
16. Considerations for using engineered animals
17. Engineered models in pharmaceutical research
18. Pharmaceutical careers for engineered animals
19. Screening for genetic toxicology
20. Carcinogenicity testing with engineered mice
21. Induced tumor rate in engineered models
22. Industrial practice for carcinogenicity testing
23. The Trp53 heterozygous mouse model
24. The Tg.Ac mouse model
25. rasH2 mouse model for short-term carcinogenicity
26. Carcinogenicity assay - study design
27. Carcinogenicity assay - hypothetical results
28. Improvement in carcinogenicity testing
29. Other mutant mouse models
30. Mutagenicity testing with transgenic mice
31. Abbreviations
32. The molecular basis of the Big Blue mouse model
33. Mutagenicity testing protocol
34. The Big Blue mouse mutagenicity assay
35. The Muta mouse mutagenicity assay
36. In-vivo mutagenicity assay - study design
37. Decision tree for carcinogenicity testing
38. Engineered animals: assessing adverse outcomes
39. Beta-secretase as a therapeutic target
40. Impact of chronic beta-secretase blockade
41. Artemin therapy for treating peripheral neuropathy
42. Neural changes in adrenal after Artemin exposure
43. Impact of Artemin supplementation
44. Summary
45. Further references

Topics Covered

• Engineered animals in drug development
• Why we use them
• How we generate them
• How we characterize them
• How we select which model to use
• How we use them

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Publication History

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

Financial Disclosures

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