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Navigable Slide Index

1. Introduction
2. GLP principles in short term studies
3. Note
4. Short-term studies OECD guidance documents
5. The OECD definition for short-term studies
6. Types of short-term studies
7. In-vitro studies definition
8. Study plan for short-term studies
9. Supplements to study plan
10. Revision of study reports
11. Responsibilities in short-term studies
12. Quality assurance programme (QAP)
13. Types of QA inspections
14. Process-based inspections
15. Frequency of inspections
16. Physical-chemical studies
17. Physical-chemical studies: specific aspects (1)
18. Physical-chemical studies: specific aspects (2)
19. Physical-chemical studies: specific aspects (3)
20. In vitro studies
21. In-vitro studies: Study director
22. In-vitro studies: Contamination
23. Identification, documentation & maintenance
24. Assurance of proper use of test system
25. SOPs for health status evaluation of systems
26. Control groups assurance
27. Culture media
28. Characterisation information for test items
29. Test guidelines for proper performance of system
30. Ad hoc SOPs
31. Major safety aspects relevant to in-vitro studies
32. Remark 1
33. Remark 2
34. Conclusions

Topics Covered

• In vitro studies
• Short-term studies
• Acute toxicity studies
• Acute ecotoxicological studies
• Genetic toxicity testing
• Standardized general study plan
• Study-specific supplement
• Standardised final report
• Process-based inspections
• Standard operating procedures
• Test item
• Reference item
• Contamination of batches
• Characterisation of culture media
• Predictive capacity of in-vitro studies
• Assessment of health effects

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on July 18, 2013

Financial Disclosures

• Prof. Sergio Caroli has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.