related to receptor theory, where EC5 0 is the parameter characterizing the potency of the drug on the biomarker and n is a sigmoidicity factor describing the drug concentration vs. the effect on the biomarkers or the number of molecules interacting at the biomarker receptor. Although the Emax model is highly versatile for different situations, more sophisticated PD models have been developed over the last decades.

PK/PD modeling builds the bridge between these two classical disciplines of pharmacology, as depicted in Figure 3. PK/PD modeling is performed to gain greater insight into how drug concentrations may affect the biomarker as well as how the models can be used to perform simulations in order to predict changes in biomarker levels under a variety of experimental conditions. Models can improve the prediction and assessment of patient response with the use of simulations, and therefore increase the success of a drug development program [13-15]. For example, the models can be used to refine a dosing regimen in order to predict the drug exposure (PK modeling) and the resulting effect on the biomarker, to guide starting doses and regimens (as well as adjustments of dosage or dosing regimens in special populations), and to provide a better understanding of outcomes from clinical efficacy studies. Case studies will be presented to demonstrates how biomarkers, together with PK/PD modeling and simulation, provide a continuous process to link what has been learned from today's drug development cycle to the next generation of biomarkers, assays, and models.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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