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- Introduction
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29 min
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14 min
2. Overview of nonclinical safety assessment- Dr. Claudette L. Fuller
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12 min
3. Biological safety testing: supporting medical device combination products- Dr. Christine L. Lanning
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34 min
4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH- Dr. John Kapeghian
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48 min
- Basics of Non-clinical Toxicity Testing
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20 min
6. Acute, subchronic, and chronic toxicity testing- Mr. Gregory Ruppert
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56 min
7. Safety pharmacology in human pharmaceutical development- Dr. R. Dusty Sarazan
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42 min
8. Genetic toxicology- Dr. Roderick Todd Bunch
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48 min
9. Reproductive and developmental toxicology- Dr. Alan Hoberman
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48 min
10. Juvenile toxicity testing- Dr. Alan Hoberman
- Dr. Elise Lewis
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43 min
11. Pharmacokinetics, toxicokinetics and safety margins- Dr. Mark Rogge
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48 min
12. Toxicity testing of impurities and metabolites- Dr. Kurt Black
- Organ System Toxicity Testing
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38 min
13. Drug induced liver injury: a clinical perspective- Prof. Victor Navarro
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62 min
14. Toxicology of the kidney- Prof. Lawrence Lash
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58 min
15. Toxicology of the cardiovascular system- Dr. Peter Siegl
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67 min
16. Toxicology of the immune system- Dr. Leigh Ann Burns Naas
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59 min
17. Toxicology of the developing immune system- Dr. Leigh Ann Burns Naas
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43 min
18. Hematology interpretation for toxicity studies- Dr. Nancy Everds
- New Methods for Assessing Toxicity
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45 min
19. Introduction to toxicogenomics and example case studies- Dr. Cindy Afshari
- Special Cases for Toxicity Testing
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46 min
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32 min
21. Approaches to nonclinical vaccine development- Dr. Lisa Plitnick
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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
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56 min
23. Cellular and molecular toxicology- Dr. Dominic Williams
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31 min
24. Overview of non-clinical safety assessment in drug development- Dr. Danuta Herzyk
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42 min
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56 min
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22 min
27. Reproductive and developmental toxicology- Dr. Alan Hoberman
- Dr. Elise Lewis
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13 min
28. Non-clinical toxicity testing for vaccines- Dr. Lisa Plitnick
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36 min
29. Toxicity testing for oncology drugs- Dr. Theresa Reynolds
- Dr. Krishna Allamneni
Printable Handouts
Navigable Slide Index
- Introduction
- Scope of presentation
- Why toxicology testing?
- Role of safety assessment in drug development
- Goals of nonclinical testing (1)
- Goals of nonclinical testing (2)
- Goals of nonclinical testing (3)
- Key scientific disciplines within toxicology
- Types of toxicology studies
- Deciding what studies to perform
- Regulation on non-clinical safety studies
- ICH safety guidelines
- Nonclinical safety guidelines for vaccines
- Toxicology studies for first-in-human clinical trials
- Genetic toxicology
- Safety pharmacology studies - in vitro
- Safety pharmacology studies - in vivo
- General toxicology studies
- Toxicology studies for late clinical development
- Developmental and reproductive toxicology
- Carcinogenicity studies
- Nonclinical studies for marketing approval
- Biologics as different class of pharmaceuticals
- Regulation of biologics
- Increasing levels of molecular complexity
- Safety evaluation of biologics (1)
- Safety evaluation of biologics (2)
- Safety evaluation of biologics (3)
- Are animal studies predictive of clinical outcome?
- Summary
- Acknowledgements
Topics Covered
- Toxicology studies of drug candidates as a critical part of safety evaluation in non-clinical and clinical development of new medicines
- Goals, types and extent of toxicity studies in different phases of drug development
- Comparison of small chemical drugs and large therapeutic molecules (biopharmaceuticals)
Links
Series:
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Talk Citation
Herzyk, D. (2010, August 9). Overview of non-clinical safety assessment in drug development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/CKKW9348.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Danuta Herzyk has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
