2011

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Editors:

ISBN: 978-3-540-89890-0 (Print) 978-3-540-89891-7 (Online)

Table of contents (39 entries)

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  1. Front Matter

    Pages i-xii

  2. Introduction

    1. Front Matter

      Pages 1-1

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      Pages 3-3

      General Introduction

  3. Clinical Pharmacokinetics

    1. Front Matter

      Pages 5-5

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      Pages 7-7

      Introduction

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      Pages 9-13

      Dose Finding in Single Dose Studies by Allometric Scaling

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      Pages 15-21

      Multiple Dose Studies

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      Pages 23-40

      Dose Linearity and Proportionality

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      Pages 41-48

      Effects of Food Intake

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      Pages 49-53

      Special Populations: Profiling the Effect of Obesity on Drug Disposition and Pharmacodynamics

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      Pages 55-61

      Special Populations: Renal Impairment

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      Pages 63-66

      Special Populations: Hepatic Impairment

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      Pages 67-71

      Special Populations: Protein Binding Aspects

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      Pages 73-103

      The Human ADME Study

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      Pages 105-118

      Synthesis of Radiolabeled Compounds for Clinical Studies

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      Pages 119-131

      Drug–Drug Interaction Studies

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      Pages 133-160

      In Vitro/In Vivo Correlation for Drug–Drug Interactions

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      Pages 161-172

      Specific Studies for Formulation Development

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      Pages 173-180

      Absolute and Relative Bioavailability

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      Pages 181-188

      Bioequivalence

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      Pages 189-205

      Population Pharmacokinetics in Clinical Pharmacology

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      Pages 207-221

      Bioanalysis of Clinical Studies

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      Pages 223-244

      Biomarker Definition and Validation During Drug Development

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