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Chapter 1
Current Methods for Prediction of Human Hepatic Clearance Using In Vitro
Intrinsic Clearance
| 1.1 |
 |
Introduction |
| 1.2 |
Materials |
| 1.3 |
Methods |
| 1.3.1 |
Thawing the hepatocytes |
| 1.3.2 |
Clearance study using a hepatocyte suspension |
| 1.3.3 |
Clearance study using a plated hepatocyte culture |
| 1.3.4 |
Clearance study using a plated hepatocyte culture under a flow
condition |
| 1.3.5 |
Sampling for the clearance study |
| 1.3.6 |
Sample analysis using LC-MS/MS |
| 1.4 |
Data Acquisition, Anticipated Results, and Interpretation |
| 1.4.1 |
Hepatocyte suspension and plated hepatocyte system |
| 1.4.2 |
Physiologically based microfluidic systems |
| 1.5 |
Discussion and Commentary |
| 1.5.1 |
Hepatocyte suspension system |
| 1.5.2 |
Plated hepatocyte system |
| 1.5.3 |
Physiologically based microfluidic systems |
| 1.6 |
Summary, References |
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Chapter 2
Use of Permeability from Cultured Cell Lines and PAMPA System and Absorption
from Experimental Animals for the Prediction of Absorption in Humans
| 2.1 |
 |
Introduction |
| 2.2 |
Materials |
| 2.3 |
Methods |
| 2.3.1 |
Cultured cell system |
| 2.3.2 |
PAMPA system |
| 2.3.3 |
In vivo absorption measurements |
| 2.4 |
Data Acquisition, Anticipated Results, and Interpretation |
| 2.4.1 |
Data analysis |
| 2.4.2 |
Results and interpretation |
| 2.5 |
Discussion and Commentary |
| 2.5.1 |
Cell culture and PAMPA systems |
| 2.5.2 |
Absorption in experimental animals |
| 2.5.3 |
Rats |
| 2.5.4 |
Dogs |
| 2.5.5 |
Monkeys |
| 2.6 |
Summary, References |
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