Drug development is a complex, lengthy and expensive process. Pharmaceutical
companies and regulatory authorities have recognised that the drug development process …

With the advancement of both biological and computer sciences, new drug development
faces the challenge to integrate a huge amount of knowledge accumulated from the very …

In a health care environment dominated by the growth of managed care organizations,
generic competition, therapeutic substitution and drug utilization review, drug development …

In the past decade considerable progress has been made in the field of integrated
pharmacokineticpharmacodynamic modelling, as can be deduced from the considerable …

Background and objective This case study describes the pharmacokinetic and
pharmacodynamic modelling undertaken during the development programme for UK …

There is broad recognition, within the pharmaceutical industry that the drug development
process, especially the clinical part of it, needs considerable improvement to cope with rapid …

We propose a framework for considering the role of pharmacokinetic/pharmacodynamic
modeling in drug development and an appraisal of its current and potential impact on that …

Pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) are well-
recognized powerful tools that enable effective implementation of the learn-and-confirm …

High development costs and low success rates in bringing new medicines to the market
demand more efficient and effective approaches. Identified by the FDA as a valuable …

In addition to more detailed consideration of the basic principles compared to the
introductory text, the current textbook expands greatly on why individuals vary in their …