Registration for a live webinar on 'Neuroleptic malignant syndrome' is now open.
See webinar detailsWe noted you are experiencing viewing problems
-
Check with your IT department that JWPlatform, JWPlayer and Amazon AWS & CloudFront are not being blocked by your network. The relevant domains are *.jwplatform.com, *.jwpsrv.com, *.jwpcdn.com, jwpltx.com, jwpsrv.a.ssl.fastly.net, *.amazonaws.com and *.cloudfront.net. The relevant ports are 80 and 443.
-
Check the following talk links to see which ones work correctly:
Auto Mode
HTTP Progressive Download Send us your results from the above test links at access@hstalks.com and we will contact you with further advice on troubleshooting your viewing problems. -
No luck yet? More tips for troubleshooting viewing issues
-
Contact HST Support access@hstalks.com
-
Please review our troubleshooting guide for tips and advice on resolving your viewing problems.
-
For additional help, please don't hesitate to contact HST support access@hstalks.com
We hope you have enjoyed this limited-length demo
This is a limited length demo talk; you may
login or
review methods of
obtaining more access.
Printable Handouts
Navigable Slide Index
- Introduction
- Outline of presentation
- Background - impurities and metabolites
- Impurities
- Impurities - background
- Types of API impurities
- Regulatory and industry guidance
- Highlights of ICH Q3A (API impurities) (1)
- ICH thresholds for drug substance (API)
- Highlights of ICH Q3A (API Impurities) (2)
- ICH guidance recommended qualification studies
- Strategies for in vivo qualification
- In vivo qualification decision scheme
- Decision scheme for qualification of API impurities
- Alternatives to impurity qualification
- Genotoxic impurities
- Genotoxic impurities - background
- Regulatory guidance on genotoxic impurities
- Guidance on the limits of genotoxic impurities (1)
- Guidance on the limits of genotoxic impurities (2)
- Industry position paper on genotoxic impurities
- Classification of impurities
- CHMP question and answer document
- Examples - limits based on genotoxic potential
- Assessment of genotoxic potential of impurities
- Decision scheme for qualification studies
- Compound for genotoxicity qualification studies
- Residual solvents
- Residual solvents - background
- ICH guidance Q3C - residual solvents
- ICH Q3C residual solvents classes (1)
- ICH Q3C residual solvents classes (2)
- Limits for ICH class 2 solvents (1)
- Limits for ICH class 2 solvents (2)
- Drug product degradants
- Drug product degradants - background
- Impurities summary
- Toxicity testing of metabolites
- Metabolites - outline
- Metabolites - background
- Metabolites - definitions (1)
- Metabolites - definitions (2)
- Toxicity assessment of metabolites
- Considerations during drug candidate selection
- Industry position paper
- Metabolites - regulatory guidance
- FDA guidance - general considerations
- General and reproductive toxicity studies
- Genotoxicity and carcinogenicity studies
- Considerations for direct testing of metabolites
- Toxicity assessment of active human metabolites
- Case studies - metabolites
- Case study 1 - acyl glucuronide
- Case study 2 - major, active metabolite
- Case study 3 metabolite with structural alert (1)
- Case study 3 metabolite with structural alert (2)
- Toxicology testing of metabolites - summary
- Summary - impurities and metabolites
- Acknowledgments
- References - impurities (1)
- References - impurities (2)
- References - metabolites
Topics Covered
- Types of impurities and regulatory framework
- Qualification of impurities
- Special considerations for genotoxic impurities
- Residual solvents and drug product degradants
- Safety assessment of drug metabolites
Links
Series:
Categories:
Talk Citation
Black, K. (2009, July 30). Toxicity testing of impurities and metabolites [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 12, 2024, from https://doi.org/10.69645/TAVT8840.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Kurt Black has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.