|
 |
|
Chapter 7
Epigenetically Stabilized Primary Hepatocyte Cultures: A Potential Sensitive
Screening Tool for Nongenotoxic Carcinogenicity
| 7.1 |
|
Introduction |
| 7.2 |
Experimental Design |
| 7.3 |
Materials |
| 7.3.1 |
Reagents |
| 7.3.2 |
Facilities/Equipment |
| 7.4 |
Methods |
| 7.4.1 |
Isolation of hepatocytes from rat liver |
| 7.4.2 |
Cultivation of primary rat hepatocytes (Troubleshooting Table) |
| 7.5 |
Data Acquisition |
| 7.6 |
Anticipated Results and Interpretation |
| 7.7 |
Discussion and Commentary |
| 7.8 |
Application Notes |
| 7.9 |
Summary Points, Acknowledgements, References |
|
Chapter 8
A Statistical Method to Reduce In Vivo Product Testing Using Related In Vitro
Tests and ROC Analysis
| 8.1 |
|
Introduction |
| 8.2 |
Experimental Design |
| 8.3 |
Materials |
| 8.4 |
Methods |
| 8.4.1 |
Step-by-step protocol for the analysis of data using Analyse-It |
| 8.5 |
Results |
| 8.6 |
Discussion and Commentary |
| 8.6.1 |
Selecting the proper secondary test |
| 8.6.2 |
Determining the sample size for calibration and recalibration |
| 8.6.3 |
Regulatory concerns |
| 8.6.4 |
Determining the frequency of recalibration |
| 8.6.5 |
Determining the need for confirmatory testing |
| 8.6.6 |
Statistical analysis |
| 8.7 |
Summary Points, Acknowledgments, References |
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