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1. Introduction
2. Definitions
3. Test item definition
4. Reference item definition
5. Test system definition
6. Cooperation with the sponsor
7. Two basic types of test systems
8. Physical-chemical test systems
9. Instrumentation used for the generation of data
10. Short-term studies
11. Physical-chemical test systems - summary
12. Biological test systems
13. Examples of biological test systems
14. Animals and plants
15. Newly received animals
16. Key questions in the case of animal test systems
17. The health conditions of animals
18. Design and construction of animal facilities
19. Conditions of animal facilities
20. Control of movement
21. Control of environmental conditions
22. Health monitoring
23. Administration of test item, necropsy & dosing
24. In vivo experimental data
25. Ensuring the scientific validity of the studies
26. Records and identification of test items
27. When test items are supplied by the sponsor
28. Test items supplied and administered in a vehicle
29. Increasing importance of in vitro systems

Topics Covered

• Animal rooms
• Biological test systems
• Characterization of test systems
• Choice of test systems
• Definition of test item
• Definition of test system
• Integrity of Good Laboratory Practice studies
• Isolation of biological test systems
• Performing of Good Laboratory Practice studies
• Physical-chemical test systems
• Proper characterization of the test item in cooperation with the sponsor
• Proper identification of the test item in cooperation with the sponsor
• Quarantine of biological test systems
• Separation of biological test systems
• Storage facilitie

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on July 18, 2013