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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.
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.
This edition includes both updates and new uses and issues
concerning CTS, along with case studies of how clinical trial
simulations are being applied in various therapeutic and
application areas. Importantly, the book expands on the utility of
CTS for informing decisions during drug development and regulatory
review. Each chapter author was selected on the basis of
demonstrated expertise in state-of-the-art application of CTS. The
target audience for this volume includes researchers and scientists
who wish to consider use of simulations in the design, analysis, or
regulatory review and guidance of clinical trials. This book does
not embrace all aspects of trial design, nor is it intended as a
complete recipe for using computers to design trials. Rather, it is
an information source that enables the reader to gain understanding
of essential background and knowledge for practical applications of
simulation for clinical trial design and analysis. It is assumed
that the reader has a working understanding of pharmacokinetics and
pharmacodynamics, modeling, pharmacometric analyses, and/or the
drug development and regulatory processes.
This edition includes both updates from the previous book titled
Simulation for Designing Clinical Trials and new uses and issues
concerning clinical trial simulations (CTS) along with case studies
of how clinical trial simulations are being applied in various
therapeutic and application areas. Importantly, the book expands on
the utility of CTS for informing decisions during drug development
and regulatory review. Each chapter was written by esteemed authors
who have demonstrated expertise in state-of-the-art application of
CTS. The target audience for this book includes not only
researchers and scientists who wish to consider use of simulations
in the design, analysis, or regulatory review and guidance of
clinical trials, but also academic researchers and others working
in drug development (e.g., clinicians, senior managers, project
planning and regulatory affairs professionals). The focus is more
on how the authors have used clinical trial simulation in decision
processes instead of illustrating detailed technical aspects. This
book is an information source that enables the reader to gain
overall knowledge on how clinical trial simulations can be used to
improve the efficiency, informativeness, speed and economy of
model-based drug development and regulation.
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