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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
- Agenda
- Goals of preclinical safety evaluation
- Differences defined by product attributes
- Product attributes differences "in general"
- "A blurring of product attributes"
- Composite of product attributes
- Predicting human risk
- Toxicological concerns in biopharmaceuticals
- ICH guidance for safety evaluation
- What is "case-by-case" approach
- Principles vs. practices
- "Case-by-case" approach (across product classes)
- "Case-by-case" approach (within a product class)
- Species / animal model selection
- Key considerations in model selection
- Dose response for biopharmaceuticals
- Immunogenicity in biopharmaceuticals
- Effects of "clearing" antibodies
- Effects of "sustaining" antibodies
- Drug induced neutralizing antibodies
- General toxicity
- General toxicity considerations
- Reproductive and developmental toxicity studies
- Reproductive toxicity: species selection
- Reproductive toxicity: fertility
- Reproductive toxicity: EF/PPND
- Infliximab
- Daclizumab
- Reproductive toxicity: communicating risk
- Carcinogenicity assessment: purpose
- Carcinogenicity: a variety of approaches
- Carcinogenicity assessment: how and when
- Carcinogenicity: alternative approaches
- Carcinogenic risk: cause for concern
- Assessment of carcinogenic risk
- Communication of carcinogenic risk
- Specific considerations: ERTs
- Specific considerations: mAbs
- Specific considerations: ODNs
- FDA guidance for estimating MRSD
- First in human dose selection (1)
- Estimating safe starting dose
- First in human dose selection (2)
- FIH/FIP dose selection: consideration of exposure
- NOAEL vs. MABEL approach
- Acceptable dose multiples
- Addendum to ICH S6
- Intended outcomes of the addendum
- Safer medicine - changing current culture
- Safer medicine - increasing dialogue
- Conclusions
- Acknowledgements
- References (1)
- References (2)
Topics Covered
- Optimization of the clinical development of biopharmaceuticals over the past two decades has relied upon the careful design and judicious use of animals in preclinical studies
- This is not only to allow for the early initiation of clinical studies but to support an uninterrupted clinical development program
- The approach has been referred to as "case-by-case", an approach which is science-based, question-based, experience-based and targeted based upon product attributes
Links
Series:
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Talk Citation
Cavagnaro, J. (2009, July 30). Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 24, 2024, from https://hstalks.com/bs/1353/.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Joy Cavagnaro has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials
Published on July 30, 2009
46 min
A selection of talks on Pharmaceutical Sciences
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