Systems Pharmacology and Pharmacodynamics (eBook)

Donald E. Mager, Holly H.C. Kimko (Herausgeber)

eBook Download: PDF

2016 | 1st ed. 2016
XIII, 511 Seiten
Springer International Publishing (Verlag)
978-3-319-44534-2 (ISBN)

Infos

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

Donald E. Mager is an Associate Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York (UB). Prior to joining the faculty at UB, Dr. Mager completed two years of post-doctoral training as an IRTA Fellow at the National Institute on Aging of the NIH. He has received the University at Buffalo Young Investigator Award and the New Investigator Award in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism from AAPS. Dr. Mager has taught as a Visiting Professor at the University Paris Descartes. He currently serves on the Clinical Pharmacology Advisory Committee to the FDA and the Editorial Advisory Boards of Biopharmaceutics and Drug Disposition and Journal of Pharmacokinetics and Pharmacodynamics. He was also elected as a Fellow to the American College of Clinical Pharmacology, as Chair of the Clinical Pharmacology and Translational Research section of AAPS, and as a member of the Board of Directors to the American Society of Pharmacometrics. His research focuses on identifying molecular and physiological factors that control the pharmacological properties of various drugs including anti-cancer, immunomodulatory, and anti-platelet drugs. He has contributed to over 69 peer-reviewed publications.

Holly Kimko is a scientific director and Janssen Fellow at Janssen Research & Development. Dr. Kimko earned her Ph.D. at the State University of New York at Buffalo (UB), specializing in the pharmaceutical sciences. Her research interests include dose-concentration in relationship to pharmacological effects and other processes of drug development. She is a technical expert of pharmacokinetic/pharmacodynamic modeling (PK/PD), and she designs clinical trial scenarios with computer simulation techniques to ensure the highest probabilities of success. She serves as the themed section editor of Current Pharmacology Reports: Pharmacometrics. Dr. Kimko serves on the editorial board of Journal of Pharmacokinetics and Pharmacodynamics. She is the co-editor of a book and a co-author of numerous publications.

Autor

Donald E. Mager is a Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York. He also served as a Visiting Professor at the University Paris Descartes in January from 2007–2013 and 2016. He currently serves on the Clinical Pharmacology Advisory Committee to the FDA and the Editorial Advisory Boards of several journals. Dr. Mager also serves as an Associate or Consulting Editor at CPT:Pharmacometrics & Systems Pharmacology (CPT:PSP), Journal of Pharmacology & Experimental Therapeutics (JPET), and Pharmacology, Research & Perspectives (PRP). He is a former President of the International Society of Pharmacometrics and is a Fellow and member of the Board of Regents of the American College of Clinical Pharmacology. In addition, he is an expert member of the Board of Pharmaceutical Sciences at FIP and serves on the Scientific Advisory Board to Simcyp. His research focuses on identifying molecular and physiological factors that control the pharmacological properties of various drugs, with a focus on anti-cancer and immunomodulatory agents. He has contributed to 120+ peer-reviewed publications.Holly H.C. Kimko-SA"> is a senior pharmacometrician in the Global Clinical Pharmacology department at Janssen Research & Development, LLC, Spring House, PA, and Adjunct Associate Professor in the Pharmacy School of Rutgers University, New Jersey. Dr. Kimko is a Janssen Research Fellow and American Association of Pharmaceutical Scientists Fellow. She championed the use of modeling and simulations in drug development at the Center for Drug Development Science at Georgetown University Medical School, Washington, DC in 1995–2002. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in pharmaceutical sciences from the University at Buffalo, State University of New York. She has published key papers on physiologically-based indirect response modeling and applications of clinical trial simulations and has edited two books on clinical trial simulations. Her research interests include strategic application of modeling and simulation tools in all aspects of drug development and post-approval life cycle management. Among her scientific endeavors is a specialty in pediatric drug development.

Inhalt

Role of Systems Modeling in Regulatory Drug Approval.- Quantitative Systems Pharmacology: Applications and Adoption in Drug Development.- Systems Pharmacology: An Overview.- Discrete dynamic modeling: a network approach for systems pharmacology.- Kinetic Models of Biochemical Signaling Networks.- Mechanistic Models of Physiological Control Systems.- Foundations of Pharmacodynamic Systems Analysis.- Direct, Indirect, and Signal Transduction Response Modeling.- Irreversible Pharmacodynamics.- Feedback Control Indirect Response Models.- Nonlinear Mixed Effects Modeling in Systems Pharmacology.- Detecting Pharmacokinetic and Pharmacodynamic Covariates From High-Dimensional Data.- Multi-Scale Modeling of Drug Action in the Nervous System.- Mechanistic Modeling of Inflammation.- Systems Pharmacology of Tyrosine Kinase Inhibitor-Associated Toxicities.- Translational Modeling of Antibacterial Agents.- Viral Dynamic Modeling of Hepatitis C Virus Infection: Past Successes and Future Challenges.- Using Systems Pharmacology to Advance Oncology Drug Development.- Systems Pharmacology Modeling in Type 2 Diabetes Mellitus.

Produkt-Details

• Erscheint lt. Verlag: 29.11.2016
• Reihe/Serie: AAPS Advances in the Pharmaceutical Sciences Series
• Reihe/Serie: AAPS Advances in the Pharmaceutical Sciences Series
• Zusatzinfo: XIII, 511 p. 113 illus., 57 illus. in color.
• Verlagsort: Cham
• Sprache: englisch
• Themenwelt: Mathematik / Informatik ► Mathematik
• Themenwelt: Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie
• Themenwelt: Technik
• Schlagworte: Bioinformatics • Drug targets • Modeling • Pharmacokinetics • PK/PD • systems biology
• ISBN-10: 3-319-44534-0 / 3319445340
• ISBN-13: 978-3-319-44534-2 / 9783319445342