Pharmacokinetics in Drug Development Volume 1 discusses the role that pharmacokinetics plays in selected clinical study designs, including:

• first-time-in-man
• biopharmaceuticals
• special population studies

Contents

1. First-Time-in-Man Studies
2. Drug-Drug Interactions
3. Food Effect Studies
4. Bioavailability and Bioequivalence Studies
5. Mass Balance Studies
6. Design, Conduct, and Analysis of Studies in Patients with Hepatic Impairment
7. Design, Conduct, and Analysis of Studies in Patients with Renal Impairment
8. Special Populations
9. Non-compartmental Analysis
10. Analysis of Urine Excretion Data
11. Compartmental Models
12. The Role of Metabolite Pharmacokinetics and Pharmacodynamics in Drug Development
13. Average, Population, and Individual Bioequivalence
14. Assessment of Dose Proportionality
15. Analysis of Absorption Kinetic Data
16. Interspecies Pharmacokinetic Scaling: Principles, Applications, and Limitations
17. In Vitro Drug Metabolism Information in the Prediction of Human Pharmacokinetics
18. Practical Deconvolution
19. Population Pharmacokinetics: Applications in Industry
20. Clinical Trial Simulation
21. The Strategic Role and Application of Pharmacokinetic/Pharmacodynamic Modeling in Drug Development
22. The Analysis of Clincal Safety Data in Phase I-II Pharmacokinetic Studies

Index

Also available:
Volume 2: Regulatory and Development Paradigms

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