Search results for "break point"

showing 4 items of 4 documents

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.

2020

Abstract In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid oral dosage forms containing moxifloxacin hydrochloride as the sole active pharmaceutical ingredient. To facilitate the feasibility decision, solubility and permeability and dissolution characteristics in the context of the BCS, therapeutic index, therapeutic use, pharmacokinetic parameters, bioequivalence/bioavailability issues, drug-excipient interactions and other relevant data were taken into consideration. Moxifloxacin is a BCS class I d…

Break pointBiowaiverMoxifloxacinPharmaceutical ScienceAdministration OralBiological AvailabilityContext (language use)02 engineering and technologyPharmacologyBioequivalenceMoxifloxacin hydrochloride030226 pharmacology & pharmacyDosage formMoxifloxacin hydrochloridePermeabilityBiopharmaceutics03 medical and health sciences0302 clinical medicineMoxifloxacinMedicinePharmacokineticsTherapeutic indexActive ingredientDosage Formsbusiness.industryBiopharmaceutics Classification System021001 nanoscience & nanotechnologyBiopharmaceutics Classification SystemBioavailabilityPharmacodynamicsSolubilityTherapeutic Equivalency0210 nano-technologybusinessmedicine.drugJournal of pharmaceutical sciences
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Modeling temperature effects on mortality: multiple segmented relationships with common break points.

2008

We present a model for estimation of temperature effects on mortality that is able to capture jointly the typical features of every temperature-death relationship, that is, nonlinearity and delayed effect of cold and heat over a few days. Using a segmented approximation along with a doubly penalized spline-based distributed lag parameterization, estimates and relevant standard errors of the cold- and heat-related risks and the heat tolerance are provided. The model is applied to data from Milano, Italy.

Statistics and ProbabilityDistributed lagHot TemperatureTime FactorsInjury controlPoison controltemperature effectRisk FactorsStatisticsHumansSegmented regressionMortalitysegmented regressionWeatherSimulationMathematicsLikelihood FunctionsModels StatisticalTemperatureGeneral MedicineHeat toleranceCold TemperatureSpline (mathematics)Nonlinear systemStandard errorItalyNonlinear DynamicsLinear ModelsRegression AnalysisStatistics Probability and Uncertaintybreak pointSettore SECS-S/01 - StatisticaAlgorithmsBiostatistics (Oxford, England)
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Analyzing Temperature Effects on Mortality Within theREnvironment: The Constrained Segmented Distributed Lag Parameterization

2010

Here we present and discuss the R package modTempEff including a set of functions aimed at modelling temperature effects on mortality with time series data. The functions fit a particular log linear model which allows to capture the two main features of mortality- temperature relationships: nonlinearity and distributed lag effect. Penalized splines and segmented regression constitute the core of the modelling framework. We briefly review the model and illustrate the functions throughout a simulated dataset.

Statistics and ProbabilityDistributed lagtemperature effects segmented relationship break point P-splines RMathematical optimizationComputer scienceP-splinesRsegmented relationshipSet (abstract data type)R packageNonlinear systemBreak pointApplied mathematicsLog-linear modelbreak pointStatistics Probability and UncertaintySegmented regressionTime seriesSettore SECS-S/01 - Statisticatemperature effectslcsh:Statisticslcsh:HA1-4737SoftwareJournal of Statistical Software
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segmented: An R package to Fit Regression Models with Broken-Line Relationships

2008

Segmented or broken-line models are regression models where the relationships between the response and one or more explanatory variables are piecewise linear, namely represented by two or more straight lines connected at unknown values: these values are usually referred as breakpoints, changepoints or even joinpoints.

changepointRbreak pointsegmented regressionSettore SECS-S/01 - Statistica
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