Applications of Pharmacokinetic Principles in Drug Development

ISBN-13: 9781461348429 / Angielski / Miękka / 2013 / 550 str.

Rajesh Krishna

Opis

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.

Recenzje

"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)

Spis treści

1. Efficient and Effective Drug Development; W.A. Colburn, G. Heath. 2. Bioanalytical Methods: Challenges and Opportunities in Drug Development; M.L. Powell, S.E. Unger. 3. Prediciting Human Oral Bioavalibility using In Silico Models; L. X. Yu, et al. 4. Drug Metabolism in Preclinical Development; M.W. Sinz. 5. Interspecies Scaling; T. Lavé, et al. 6. Human Drug Absorption Studies in Early Development; D.V. Prior, et al. 7. Food-Drug Interactions: Drug Development Considerations; D. Fleisher, L. Reynolds. 8. Global Regulatory and Biopharmaceutics Strategies in New Drug Development: Biowaivers; E. Gupta, E. Yamashita. 9. Special Population Studies in Clinical Development: Pharmacokinetic Considerations; J.M. Kovarik. 10. Drug-Drug Interactions; S.M. Huang. 11. Pharmacokinetic/Pharmacodynamic Modeling in Drug Development; S. Rohatagi, et al. 12. Population Pharmacokinetic and Pharmacodynamic Modeling; R. Jelliffe, et al. 13. Role of Preclinical Metabolism and Pharmacokinetics in the Development of Celecoxib; S.K. Paulson, T.J. Maziasz. 14. The Role of Clinical Pharmacology and of Pharmacokinetics in the Development of Alendronate - A Bone Resorption Inhibitor; A.G. Porras, B.J. Gertz. 15. Optimizing Individualized Dosage Regimens of Potentially Toxic Drugs; R.W. Jelliffe, et al. Appendix. Index.