Pharmacometrics
The Science of Quantitative Pharmacology
Chapter One
Pharmacometrics: Impacting Drug
Development and Pharmacotherapy
PAUL J. WILLIAMS and ENE I. ETTE
1.1 INTRODUCTION
Drug development continues to be expensive, time consuming, and inefficient, while
pharmacotherapy is often practiced at suboptimal levels of performance.
This trend has not waned despite the fact that massive amounts of drug data are
obtained each year. Within these massive amounts of data, knowledge that would
improve drug development and pharmacotherapy lays hidden and undiscovered.
The application of pharmacometric (PM) principles and models to drug development
and pharmacotherapy will significantly improve both. Furthermore, with
drug utilization review, generic competition, managed care organization bidding,
and therapeutic substitution, there is increasing pressure for the drug development
industry to deliver high-value therapeutic agents.
The Food and Drug Administration (FDA) has expressed its concern about the
rising cost and stagnation of drug development in the whit ... read full excerpt from Pharmacometrics: The Science of Quantitative Pharmacology ebook
