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Printable Handouts
Navigable Slide Index
- Introduction
- Presentation outline
- The story of diethylene glycol and thalidomide
- The center for drugs and biologics
- Global pharmaceutical market: 1980s - 2000s
- The formation of ICH
- ICH: who, what, when, where, and why?
- Key ICH guidance documents
- Key ICH safety guidance documents
- Key ICH safety guidance - the M documents
- Steps for harmonization
- Where to find the ICH safety documents?
- How to use ICH guidance documents
- Key questions regarding your program
- Typical IND program for a small molecule
- "Highlights" of the ICH safety guidance - S1
- "Highlights" of the ICH safety guidance - S2
- "Highlights" of the ICH safety guidance - S3
- "Highlights" of the ICH safety guidance - S4
- "Highlights" of the ICH safety guidance - S5
- "Highlights" of the ICH safety guidance - S6
- "Highlights" of the ICH safety guidance - S7
- "Highlights" of the ICH safety guidance - S8
- Guidance documents: friend or foe? (1)
- Guidance documents: friend or foe? (2)
- Where are we headed?
- Future directions
- Global pharmaceutical market: beyond 2000s
- Summary
Topics Covered
- History of drug safety regulations
- Who is the ICH?
- Harmonization of toxicity testing guidelines: why?
- What guidelines currently exist and how are they applied to toxicity testing
- How guidelines are harmonized through the ICH process
- What safety guidelines are typically followed in an IND
- Issues and future considerations for harmonized safety testing guidelines worldwide
Links
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Talk Citation
Kapeghian, J. (2009, August 5). Regulatory guidance on toxicity testing of pharmaceuticals: ICH [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved June 10, 2023, from https://hstalks.com/bs/1339/.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. John Kapeghian has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.