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Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners.
AAPS J
November 2022
Office of New Animal Drugs, Center for Veterinary Medicine (CVM), US Food and Drug Administration (FDA), Rockville, Maryland, 20855, USA.
Prior to his passing, Dr. Roger Jelliffe, expressed the need for educating future physicians and clinical pharmacists on the availability of computer-based tools to support dose optimization in patients in stable or unstable physiological states. His perspectives were to be captured in a commentary for the AAPS J with a focus on incorporating population pharmacokinetic (PK)/pharmacodynamic (PD) models that are designed to hit the therapeutic target with maximal precision.
View Article and Find Full Text PDFAn Algorithm for Nonparametric Estimation of a Multivariate Mixing Distribution with Applications to Population Pharmacokinetics.
Pharmaceutics
December 2020
Laboratory of Applied Pharmacokinetics and Bioinformatics, Children's Hospital of Los Angeles, Los Angeles, CA 90027, USA.
Population pharmacokinetic (PK) modeling has become a cornerstone of drug development and optimal patient dosing. This approach offers great benefits for datasets with sparse sampling, such as in pediatric patients, and can describe between-patient variability. While most current algorithms assume normal or log-normal distributions for PK parameters, we present a mathematically consistent nonparametric maximum likelihood (NPML) method for estimating multivariate mixing distributions without any assumption about the shape of the distribution.
View Article and Find Full Text PDFThe New Direct-Acting Oral Anticoagulants Need to be Monitored!
Ther Drug Monit
June 2020
iC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.
Development of a methodology to make individual estimates of the precision of liquid chromatography-tandem mass spectrometry drug assay results for use in population pharmacokinetic modeling and the optimization of dosage regimens.
PLoS One
June 2020
Laboratory of Applied Pharmacokinetics and Bioinformatics, Children's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, United States of America.
Background: The clinical value of therapeutic drug monitoring can be increased most significantly by integrating assay results into clinical pharmacokinetic models for optimal dosing. The correct weighting in the modeling process is 1/variance, therefore, knowledge of the standard deviations (SD) of each measured concentration is important. Because bioanalytical methods are heteroscedastic, the concentration-SD relationship must be modeled using assay error equations (AEE).
View Article and Find Full Text PDFExpert Discussion of the Role of Rate Constant Versus Clearance Approaches to Define Drug Pharmacokinetics: Theoretical and Clinical Considerations.
AAPS J
January 2020
Department of Pharmacokinetics, Toxicology and Targeting, Groningen Research Institute for Pharmacy, University of Groningen Antonius Deusinglaan, 19713 AV, Groningen, The Netherlands.
This article provides a dialogue covering an ongoing controversy on the use of clearance versus rate constant approaches for model parameterization when assessing pharmacokinetic (PK) data. It reflects the differences in opinions that can exist among PK experts. Importantly, this discussion extends beyond theoretical arguments to demonstrate how these different approaches impact the analysis and interpretation of data acquired in clinical situations.
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