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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
- Toxicology and safety pharmacology studies
- Why is safety pharmacology important?
- ICH guidelines
- Scope of the S7A guidance
- ICH topic S7A - safety pharmacology
- The "core battery" of studies
- Follow up and supplemental studies
- Core battery - CNS
- Follow-up assays (CNS)
- Core battery - respiratory system
- Rodent plethysmography
- Core battery - cardiovascular system
- Telemeter cardiovascular signals - example
- QT interval prolongation
- A normal ECG and torsades de pointes (TdP)
- QT interval
- Individual cardiac action potentials and ECG
- Ionic basis of the cardiac action potential
- Action potential with IKr blockade
- In vitro IKr assay
- What is IKr?
- Significance of IKr (hERG) blockade
- In vivo QT assay
- Measurements to be made and reported
- "Rate correction" of QT (1)
- ICH comments on rate correction
- "Rate correction" of QT (2)
- Safety pharmacology studies with biologicals
- What about biologicals?
- Biologicals - the hERG assay
- Safety pharmacology endpoint in tox studies
- Regulatory significance
- CNS pharmacology in tox studies
- Respiratory pharmacology in tox studies
- Cardiovascular system in nonrodent tox studies
- Digital ECGs from a canine tox study
- ECG collection from nonhuman primates
- A solution to the problem
- Comparison of ECG effects in nonhuman primates
- Jacketed telemetry components
- Primate toxicology ECGs via bluetooth telemetry
- Resting heart rate comparison
- What about blood pressure?
- Sphygmomanometry
- High definition oscillometry (1)
- High definition oscillometry (2)
- Direct BP measurement in tox studies (1)
- Implantation of a miniature BP telemetry device
- Tracings from 2 nonhuman primates
- Direct BP measurement in tox studies (2)
- Conclusion
Topics Covered
- Adverse functional effects of drugs on vital organ systems have resulted in patient deaths and several product withdrawals over the past two decades
- The potential for these effects was not detected in the traditional toxicology studies that were conducted at the time
- These unfortunate events have led to the introduction of new international regulatory guidelines and the creation of a new discipline, known as safety pharmacology, which is distinct from toxicology
- Safety pharmacology involves experts in pharmacology who specialize in acute adverse effects of potential human drugs, primarily on the cardiovascular, respiratory and central nervous system
- These three organ systems have been deemed to be the ones that are acutely critical for life
- If safety pharmacology studies had been conducted in the past, according to today's standards, the vast majority of the drugs that resulted in human deaths would never have made it into clinical development, much less therapeutic usage in patients
Links
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Talk Citation
Sarazan, R.D. (2009, July 30). Safety pharmacology in human pharmaceutical development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/ZCDT9765.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. R. Dusty Sarazan has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.