Applications of Pharmacokinetic Principles in Drug Development

1. Front Matter

   Pages i-xvi

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2. Efficient and Effective Drug Development

   • Wayne A. Colburn, Gene Heath

   Pages 1-20

3. Bioanalytical Methods: Challenges and Opportunities in Drug Development

   • Mark L. Powell, Steve E. Unger

   Pages 21-52

4. Predicting Human Oral Bioavailability Using in Silico Models

   • Lawrence X. Yu, Christopher D. Ellison, Ajaz S. Hussain

   Pages 53-74

5. Drug Metabolism In Preclinical Development

   • Michael W. Sinz

   Pages 75-132

6. Interspecies Scaling

   • Thierry Lavé, Olivier Luttringer, Patrick Poulin, Neil Parrott

   Pages 133-175

7. Human Drug Absorption Studies In Early Development

   • David V. Prior, Alyson L. Connor, Ian R. Wilding

   Pages 177-194

8. Food-Drug Interactions: Drug Development Considerations

   • David Fleisher, Laurie Reynolds

   Pages 195-223

9. Global Regulatory And Biopharmaceutics Strategies In New Drug Development: Biowaivers

   • Elora Gupta, Elizabeth Yamashita

   Pages 225-243

10. Special Population Studies In Clinical Development: Pharmacokinetic Considerations

    • John M. Kovarik

    Pages 245-305

11. Drug-Drug Interactions

    • Shiew-Mei Huang

    Pages 307-331

12. Pharmacokinetic/Pharmacodynamic Modeling in Drug Development

    • Shashank Rohatagi, Nancy E. Martin, Jeffrey S. Barrett

    Pages 333-372

13. Population Pharmacokinetic and Pharmacodynamic Modeling

    • Roger Jelliffe, Alan Schumitzky, Aida Bustad, Michael Van Guilder, Xin Wang, Robert Leary

    Pages 373-404

14. Role of Preclinical Metabolism and Pharmacokinetics in The Development of Celecoxib

    • Susan K. Paulson, Timothy J. Maziasz

    Pages 405-425

15. The Role of Clinical Pharmacology and of Pharmacokinetics in The Development of Alendronate - A Bone Resorption Inhibitor

    • Arturo G. Porras, Barry J. Gertz

    Pages 427-475

16. Optimizing Individualized Dosage Regimens of Potentially Toxic Drugs

    • Roger W. Jelliffe, Alan Schumitzky, Robert Leary, Andreas Botnen, Ashutosh Gandhi, Pascal Maire et al.

    Pages 477-528

17. Back Matter

    Pages 529-550

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This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.

• Resorption
• absorption
• development
• drug
• drug development
• drugs
• kinetics
• metabolism
• pharmacokinetics
• pharmacology
• research

"Pharmacokinetics and pharmacodynamics (PK/PD) have become essential disciplines in drug research and development. Rational use of PK/PD allows for better decision making and streamlines dose optimization. The present book gives an excellent overview of the state of the art of PK/PD in modern drug development. The book was prepared by a group of expert scientists with vast experience in the drug development process. It is full of real-life examples, and is well-structured and easy to follow. In particular, it provides an excellent link between the preclinical and clinical phases of drug development. This book is of great value to everybody working in the field of PK/PD."
(Hartmut Derendorf, Ph.D., F.C.P., Distinguished Professor and Chairman, Dept. of Pharmaceutics, University of Florida, Gainesville)
"This is a superb book providing, to my knowledge, the best integration of the important principles of pharmacokinetics and pharmacodynamics with the FDA's regulatory policies in the development of drug products. It is not an academic approach, but rather a down to earth `how to' which is loaded with actual examples that have passed FDA muster. This book belongs on the desk and nightstand of everyone involved in the drug development process."
(Jerome P. Skelly, Ph.D., F.C.P., Pharmaceutical Consultant and Professor of Biopharmaceutics College of Pharmacy, University of Cincinnati, OH)

• Aventis Pharmaceuticals, Inc., Bridgewater, USA

  Rajesh Krishna

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