Applications of Pharmacokinetic Principles in Drug Development

• Efficient and Effective Drug Development.- Bioanalytical Methods: Challenges and Opportunities In Drug Development.- Predicting Human Oral Bioavailability using In Silico Models.- Drug Metabolism in Preclinical Development.- Interspecies Scaling.- Human Drug Absorption Studies in Early Development.- Food-Drug Interactions: Drug Development Considerations.- Global Regulatory and Biopharmaceutics Strategies in New Drug Development: Biowaivers.- Special Population Studies in Clinical Development: Pharmacoldnetic Considerations.- Drug-Drug Interactions.- Pharmacokinetic/Pharmacodynamic Modeling in Drug Development.- Population Pharmacokinetic and Pharmacodynamic Modeling.- Role of Preclinical Metabolism and Pharmacokinetics in the Development of Celecoxib.- The Role of Clinical Pharmacology and of Pharmacokinetics in the Development of Alendronate – A Bone Resorption Inhibitor.- Optimizing Individualized Dosage Regimens of Potentially Toxic Drugs.

"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)