Although the monitoring of drug therapies based on the determination of drug
concentrations in biological materials is certainly an important instrument for individualized …

A primary objective of pharmacokinetic-pharmacodynamic (PKPD) reasoning is to identify
key in vivo drug and system properties, enabling prediction of the magnitude and time …

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quickly has been critical to this development. The increased complexity of systems …

The majority of biotherapeutic drugs act on specific targets, which may serve as biomarkers
to be evaluated for target engagement and validation. Together with subsequent pathway …

dose-escalation studies if unacceptable toxicities are encountered before reaching the
projected efficacious exposure. It is also possible, however, to determine the extent (and …

Biomarkers (BMs) are biological measures of PD drug effects or disease markers that may
represent clinically significant patient outcomes, either efficacy or toxicity. Their use in drug …

The use of physiologically based pharmacokinetic (PBPK) modeling to support the drug
product quality attributes, also known as physiologically based biopharmaceutics modeling …

The application of physiologically-based pharmacokinetic (PBPK) modeling is coming of
age in drug development and regulation, reflecting significant advances over the past 10 …

Four elements are crucial to successful pharmacokinetic-pharmacodynamic (PK/PD)
modelling and simulation for efficient and effective rational drug development:(i) mechanism …

The role of pharmacokinetics (PK) in drug discovery is to support the optimisation of the
absorption, distribution, metabolism and excretion (ADME) properties of lead compounds …