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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
- Presentation outline
- The story of diethylene glycol and thalidomide
- The center for drugs and biologics
- Global pharmaceutical market: 1980s - 2000s
- The formation of ICH
- ICH: who, what, when, where, and why?
- Key ICH guidance documents
- Key ICH safety guidance documents
- Key ICH safety guidance - the M documents
- Steps for harmonization
- Where to find the ICH safety documents?
- How to use ICH guidance documents
- Key questions regarding your program
- Typical IND program for a small molecule
- "Highlights" of the ICH safety guidance - S1
- "Highlights" of the ICH safety guidance - S2
- "Highlights" of the ICH safety guidance - S3
- "Highlights" of the ICH safety guidance - S4
- "Highlights" of the ICH safety guidance - S5
- "Highlights" of the ICH safety guidance - S6
- "Highlights" of the ICH safety guidance - S7
- "Highlights" of the ICH safety guidance - S8
- Guidance documents: friend or foe? (1)
- Guidance documents: friend or foe? (2)
- Where are we headed?
- Future directions
- Global pharmaceutical market: beyond 2000s
- Summary
Topics Covered
- History of drug safety regulations
- Who is the ICH?
- Harmonization of toxicity testing guidelines: why?
- What guidelines currently exist and how are they applied to toxicity testing
- How guidelines are harmonized through the ICH process
- What safety guidelines are typically followed in an IND
- Issues and future considerations for harmonized safety testing guidelines worldwide
Links
Series:
Categories:
Talk Citation
Kapeghian, J. (2009, August 5). Regulatory guidance on toxicity testing of pharmaceuticals: ICH [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 20, 2024, from https://hstalks.com/bs/1339/.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. John Kapeghian has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.