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- Introduction
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2. Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
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3. Biological safety testing: supporting medical device combination products
- Dr. Christine L. Lanning
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4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH
- Dr. John Kapeghian
- Basics of Non-clinical Toxicity Testing
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6. Acute, subchronic, and chronic toxicity testing
- Mr. Gregory Ruppert
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7. Safety pharmacology in human pharmaceutical development
- Dr. R. Dusty Sarazan
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8. Genetic toxicology
- Dr. Roderick Todd Bunch
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9. Reproductive and developmental toxicology
- Dr. Alan Hoberman
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10. Juvenile toxicity testing
- Dr. Alan Hoberman
- Dr. Elise Lewis
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11. Pharmacokinetics, toxicokinetics and safety margins
- Dr. Mark Rogge
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12. Toxicity testing of impurities and metabolites
- Dr. Kurt Black
- Organ System Toxicity Testing
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13. Drug induced liver injury: a clinical perspective
- Prof. Victor Navarro
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14. Toxicology of the kidney
- Prof. Lawrence Lash
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15. Toxicology of the cardiovascular system
- Dr. Peter Siegl
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16. Toxicology of the immune system
- Dr. Leigh Ann Burns Naas
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17. Toxicology of the developing immune system
- Dr. Leigh Ann Burns Naas
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18. Hematology interpretation for toxicity studies
- Dr. Nancy Everds
- New Methods for Assessing Toxicity
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19. Introduction to toxicogenomics and example case studies
- Dr. Cindy Afshari
- Special Cases for Toxicity Testing
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21. Approaches to nonclinical vaccine development
- Dr. Lisa Plitnick
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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
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23. Cellular and molecular toxicology
- Dr. Dominic Williams
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24. Overview of non-clinical safety assessment in drug development
- Dr. Danuta Herzyk
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27. Reproductive and developmental toxicology
- Dr. Alan Hoberman
- Dr. Elise Lewis
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28. Non-clinical toxicity testing for vaccines
- Dr. Lisa Plitnick
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29. Toxicity testing for oncology drugs
- Dr. Theresa Reynolds
- Dr. Krishna Allamneni
Printable Handouts
Navigable Slide Index
- Introduction
- Course objectives
- The promise of engineered models
- Why examine engineered mice?
- Production and validation of engineered models
- Types of engineered animals
- Transgenic mice by microinjection
- Knockout mice (gene targeting)
- Utilization of gene targeting technology
- Validation milestones for engineered models
- Characterization of genetically engineered animals
- Sample protocol for screening engineered animals
- Standardizing genetic and environmental variables
- Selecting the most appropriate engineered model
- Approaches to functional genomics
- Considerations for using engineered animals
- Engineered models in pharmaceutical research
- Pharmaceutical careers for engineered animals
- Screening for genetic toxicology
- Carcinogenicity testing with engineered mice
- Induced tumor rate in engineered models
- Industrial practice for carcinogenicity testing
- The Trp53 heterozygous mouse model
- The Tg.Ac mouse model
- rasH2 mouse model for short-term carcinogenicity
- Carcinogenicity assay - study design
- Carcinogenicity assay - hypothetical results
- Improvement in carcinogenicity testing
- Other mutant mouse models
- Mutagenicity testing with transgenic mice
- Abbreviations
- The molecular basis of the Big Blue mouse model
- Mutagenicity testing protocol
- The Big Blue mouse mutagenicity assay
- The Muta mouse mutagenicity assay
- In-vivo mutagenicity assay - study design
- Decision tree for carcinogenicity testing
- Engineered animals: assessing adverse outcomes
- Beta-secretase as a therapeutic target
- Impact of chronic beta-secretase blockade
- Artemin therapy for treating peripheral neuropathy
- Neural changes in adrenal after Artemin exposure
- Impact of Artemin supplementation
- Summary
- 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:
Categories:
Talk Citation
Bolon, B. (2009, July 30). Non-clinical development of pharmaceuticals using engineered animal models [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/WEFV7181.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Brad Bolon has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
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