Pettitt, Anthony N.: Simulation-based fully Bayesian experimental design for mixed effects models (2015)
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The appropriate statistical analysis using the appropriate model helps pharmaceutical companies determine appropriate dosing strategies for their products, and increases their understanding of drug mechanisms and interactions.NONMEM software was originally developed by Lewis Sheiner and Stuart Beal and the NONMEM Project Group at the University of California, and has been used for over 30 years for population analysis by many pharmaceutical companies and the PK/PD modeling community. It solves pharmaceutical statistical problems in which within subject and between subjects variability is taken into account when fitting a pharmacokinetic and/or pharmacodynamic (PK/PD) model to data. NONMEM is a computer program that is implemented in Fortran90/95. NONMEM stands for NONlinear Mixed Effects Modeling. Often we wish to also take into account the robustness of a design, that is, determine a sampling strategy that is rich enough to account for the variations in PK/PD parameters that are likely to occur in a set of subjects.NONMEM® is a nonlinear mixed effects modelling tool used in population pharmacokinetic/pharmacodynamic analysis. For example, we may want to determine the sample times which gives us the lowest possible standard errors to the population parameters, or determine cohorts that a have the ideal combination of dosing regimen and sample times. In particular, good quality parameters of the PK/PD model describing that therapeutic in humans desired.
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The goal of clinical trial design is to find times and doses that are most efficient and economical to obtain the desired information about a therapeutic.
In addition, the tools and techniques of clinical trial design and evaluation and optimization are discussed. The numerical integrator tools and techniques required to model each type of delay is discussed, describing their behavior, and their pros and cons in terms of ease of use, efficiency, stability, and stiffness. These delays may be modelled either as a discrete delay, or as a distributed delay, the most common being gamma distributed and Weibull distributed. Algorithms that model delays for biological problems are explained, particularly cell lifespan and cell maturation are discussed. Two major features newly developed in NONMEM 7.5 are modelling delays, and clinical trial design evaluation and optimization. Understanding the Methodology and Uses of Some New Features in NONMEM 7.5: Clinical Trial Design Evaluation and Optimization, and Delay Differential Equations Pharmacometrics and PK/PD Modeling & Simulation, ICON Clinical Research, LLC.
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