Applications of Pharmacokinetic Principles in Drug Development
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Applications of Pharmacokinetic Principles in Drug Development by Rajesh Krishna
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.
"Pharmacokinetics and pharmacodynamics (PK/PD) have become essential disciplines in drug research and developmentRational 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)
(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)
Littman, Bruce H.: - Rajesh Krishna, PhD, FCP, is an area lead director in early stage development at Merck Research Laboratories. Dr Krishna is the editor of three books on new drug development besides publishing over 120 articles and oral/poster presentations. He has served as a section editor for the Journal of Clinical Pharmacology, associate editor for BMC Clinical Pharmacology and an editorial board member for BMC Medicine. He is a Fellow of the American College of Clinical Pharmacology and the American Association of Pharmaceutical Scientists, where he is the current Chair of the Clinical Pharmacology and Translational Research section. He is an affiliate member of the Institute of Translational Medicine and Therapeutics at the University of Pennsylvania.
| SKU | Unavailable |
| ISBN 13 | 9780306477669 |
| ISBN 10 | 0306477661 |
| Title | Applications of Pharmacokinetic Principles in Drug Development |
| Author | Rajesh Krishna |
| Condition | Unavailable |
| Binding Type | Hardback |
| Publisher | Springer |
| Year published | 2003-10-31 |
| Number of pages | 550 |
| Cover note | Book picture is for illustrative purposes only, actual binding, cover or edition may vary. |
| Note | Unavailable |