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Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics.

The modeling framework successfully predicted survival in a phase III trial on the basis of capecitabine phase II data in CRC and is a useful tool to support end-of-phase II decisions and design of phase III studies.
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Pharmacodynamics of Oral Ganciclovir and Valganciclovir in Solid Organ Transplant Recipients

The greater systemic exposure to ganciclovir delivered by valganciclovIR was associated with delayed development of viremia, and there was only a weak association between AUC and hematological toxicity.
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Allometric relationships between the pharmacokinetics of propofol in rats, children and adults.

On the basis of data obtained after a single bolus injection in the rat, adequate predictions of propofol concentrations in critically ill patients can be made using allometric equations, despite the long-term nature of the use of the drug, the large number of infusion changes per day and/or differences in state of health and age.
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Comparative population pharmacokinetics of lorazepam and midazolam during long-term continuous infusion in critically ill patients.

Inclusion of alcohol abuse and age as covariates improved both models, and the pharmacokinetics of both lorazepam and midazolam were well described by a two-compartment model.
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Population pharmacokinetic and pharmacodynamic modeling of propofol for long‐term sedation in critically ill patients: A comparison between propofol 6% and propofol 1%

A population pharmacokinetic and pharmacodynamic model of propofol for long‐term sedation in critically ill patients is described, because limited information is available in these patients. In the…
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Allometric Scaling of Pharmacodynamic Responses: Application to 5-Ht1A Receptor Mediated Responses from Rat to Man

Allometrically scaled mechanism based PK–PD models are promising as a means of predicting the pharmacodynamic responses in man and provides for a novel way of interpreting and scaling pre-clinical pharmacological responses.
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Population pharmacodynamic modelling of lorazepam- and midazolam-induced sedation upon long-term continuous infusion in critically ill patients

The population pharmacodynamic model shows a similarly wide intra- and inter-individual variability in the pharmacodynamics of both lorazepam and midazolam, indicating that the previously observed differences in “ease of titration” between l orazep am and midzolam are unrelated to pharmacodynamic factors.
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A set-point model with oscillatory behavior predicts the time course of 8-OH-DPAT-induced hypothermia.

A physiological model that can be used to predict the complex time course of the hypothermic response after administration of 5-HT(1A) agonists to rats showed oscillatory behavior, and revealed that the observed difference in effect vs. time profile for these two reference agonists could be explained by a difference in in vivo intrinsic efficacy.
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Pharmacokinetic-Pharmacodynamic Modeling of Buspirone and Its Metabolite 1-(2-Pyrimidinyl)-piperazine in Rats

The results of this analysis show that buspirone and 1- PP behave as partial 5-hydroxytryptamine1A agonists in vivo and that following intravenous administration the amount of 1-PP formed is too small to contribute to the hypothermic effect.
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Mechanism-Based Pharmacokinetic-Pharmacodynamic Modeling of 5-HT1A Receptor Agonists: Estimation of in Vivo Affinity and Intrinsic Efficacy on Body Temperature in Rats

A full mechanistic PK-PD model for 5-HT1A receptor agonists has been obtained, which is highly predictive of the in vivo intrinsic efficacy and a highly significant correlation was observed between the efficacy parameters in vivo and in vitro.
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