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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
- Talk objectives
- Reproductive and developmental toxicology
- Field background
- Why is this field important?
- Birth defects incidence
- Birth defects - past examples
- Guidance for testing
- Defining the guidance for testing
- Intentional and unintentional exposure
- Underlying principles
- Other underlying principles
- Underlying principles - examples
- Underlying principles - death or failure to thrive
- Underlying principles - malformation
- Underlying principles - growth retardation
- Underlying principles - functional deficits
- Basic guidelines
- Basic guidelines - drugs
- Chemicals (OECD or EPA- specific)
- Foods and food additives
- Guidance for intentional exposure (drugs)
- Reproductive and developmental effects
- ICH guidelines S5R - choice of studies
- Unintentional exposure
- Guidance for unintentional exposure
- OECD guidelines for the testing of chemicals
- Reproductive and developmental toxicity endpoints
- Paternal/maternal endpoints
- Reproductive endpoints
- Developmental endpoints
- Developmental endpoints - functional testing
- Outcomes
- Conclusions
Topics Covered
- Assessing the risk of exposure to a new pharmaceutical is critical in providing information on the safe and effective use of any new product
- Reproductive and developmental toxicology is the study of the potential adverse effect of a drug, chemical, consumer product or medical device on the ability of a male and female to produce healthy normal children
- Adverse outcomes have lead to the safety testing that is mandated
- The guidelines that outline the safety testing required, the principles that these guidelines are based on and the potential hazard assessments that are made are based on the test results
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Hoberman, A. and Lewis, E. (2009, July 30). Reproductive and developmental toxicology [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/XOEB9146.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
- Dr. Elise Lewis has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.