APPLICATION OF PK MODELLING FOR RIVAROXABAN Sample Clauses

APPLICATION OF PK MODELLING FOR RIVAROXABAN. The pharmacokinetics of rivaroxaban describes the time course of its concentration in vivo. Studies using high performance liquid chromatography-tandem mass spectrometry to measure rivaroxaban concentration, have been used to calculate the pharmacokinetics of rivaroxaban. (Xxxxxxx et al., 2008; Xxxxxxx et al., 2013) PPK plays a crucial role in developing dosing strategies for drug development and providing detailed information for a target patient group. The specific covariate impacting on the drug in question can then be identified. The advantage of PPK method is that sparse data collection can be used to calculate PK parameters for the drug in question. The pharmacodynamics of rivaroxaban, which illustrates the relationship between rivaroxaban dose and effect, is less comprehensively understood, due to both the complexity of the coagulation system in vivo and the limitations of the current laboratory tools for measuring this. Post-marketing research is essential to enable a full understanding of the effectiveness of rivaroxaban, its potential for adverse effects and how quickly and long- lasting the beneficial and adverse effects may be. Inferences on how the pharmacokinetics (PK) of a drug determine its pharmacodynamics (PD), as measured in individuals, can be made using PK-PD population modelling. Pharmacokinetic and pharmacodynamic (PK-PD) modelling for rivaroxaban characterise the PK parameters of rivaroxaban and links them to its PD activity in a conceptual framework model. PK-PD population modelling is the application of this PK-PD model to a general population for describing data, derived from more than one individual, by borrowing information between individuals to fill in gaps in the PK-PD profiles of each individual. Crucially, rivaroxaban is prescribed as a fixed dose for all patients, with a few exceptions. It is accepted that every individual has a specific response to any drug, which is characterised by predictable and unpredictable PK outcomes. In order to maximise an individual’s response to a drug, the PK profiling must be described as comprehensively as possible, identifying as many covariates and unpredictable inter-individual variables as possible, termed co-variants. A set of statistical techniques is applied, enabling understanding of the typical response in a population and the variability in that response which arises from various factors. PK population modelling is an important tool to integrate data and knowledge, enabling quant...
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