Bioequivalence testing by statistical shape analysis.

abstract：:The volume of distribution at steady state (Vss) of therapeutic proteins is usually assessed by non-compartmental or compartmental pharmacokinetic (PK) analysis wherein errors may arise due to the elimination of therapeutic proteins from peripheral tissues that are not in rapid equilibrium with the sampling compartmen...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Richter WF,Grimm HP,Theil FP

更新日期：2011-10-01 00:00:00

abstract：:This study was designed to investigate ethnic differences in the pharmacokinetics (PKs) of moxifloxacin and its metabolites, M1 (sulfo conjugate) and M2 (acyl-glucuronate), among Japanese, Chinese, and Korean populations, following oral administration. We used a population PK modeling approach using data from a clinic...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Kaneko M,Aoyama T,Ishida Y,Miyamoto A,Saito Y,Tohkin M,Kawai S,Matsumoto Y

更新日期：2018-04-01 00:00:00

abstract：:Population pharmacokinetic-pharmacodynamic analysis involves nonlinear hierarchical modelling where the mean response in a population and the variability in response from different sources are studied. It generally consists of two model hierarchies: a model for residual error and a model for heterogeneity termed betwe...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Lagishetty CV,Vajjah P,Duffull SB

更新日期：2012-08-01 00:00:00

abstract：:Cell-level kinetic models for therapeutically relevant processes increasingly benefit the early stages of drug development. Later stages of the drug development processes, however, rely on pharmacokinetic compartment models while cell-level dynamics are typically neglected. We here present a systematic approach to int...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Krippendorff BF,Oyarzún DA,Huisinga W

更新日期：2012-04-01 00:00:00

abstract：:Drugs that bind with high affinity and to a significant extent (relative to dose) to a pharmacologic target such as an enzyme, receptor, or transporter may exhibit nonlinear pharmacokinetic (PK) behavior. Processes such as receptor-mediated endocytosis may result in drug elimination. A general PK model for characteriz...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Mager DE,Jusko WJ

更新日期：2001-12-01 00:00:00

abstract：:We propose an efficient algorithm for screening covariates in population model building using Wald's approximation to the likelihood ratio test (LRT) statistic in conjunction with Schwarz's Bayesian criterion. The algorithm can be applied to a full model fit of k covariate parameters to calculate the approximate LRT f...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Kowalski KG,Hutmacher MM

更新日期：2001-06-01 00:00:00

abstract：:HER2-positive breast cancer (BC) is a rapidly growing and aggressive BC subtype that predominantly affects younger women. Despite improvements in patient outcomes with anti-HER2 therapy, primary and/or acquired resistance remain a major clinical challenge. Here, we sought to use a quantitative systems pharmacological ...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Franco YL,Ramakrishnan V,Vaidya TR,Mody H,Perez L,Ait-Oudhia S

更新日期：2021-01-03 00:00:00

abstract：:This study aimed to characterize pharmacodynamic interaction between propofol and aminophylline. Nine beagle dogs were randomly allocated at the propofol rates of 0.75 (group A), 1.00 (group B), and 1.25 (group C) mg/kg/min. During period 1, propofol only was infused, while during period 2, aminophylline only, at the ...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Lee SH,Kang HJ,Jin SJ,Park DY,Choi YJ,Choi BM,Lee EK,Noh GJ

更新日期：2014-12-01 00:00:00

abstract：:There has been little evaluation of maximum likelihood approximation methods for non-linear mixed effects modelling of count data. The aim of this study was to explore the estimation accuracy of population parameters from six count models, using two different methods and programs. Simulations of 100 data sets were per...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Plan EL,Maloney A,Trocóniz IF,Karlsson MO

更新日期：2009-08-01 00:00:00

abstract：:Changes in the reticulocyte subtype distribution (high, medium and low reticulocytes count (HR, MR, LR)) measured by flow cytometry following phlebotomy-induced stress erythropoiesis (abruptly dropping hemoglobin to 3-4 g/dl over 4-5 hr) and the pharmacodynamic (PD) relationship to the stimulated erythropoietin (EPO) ...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Al-Huniti NH,Widness JA,Schmidt RL,Veng-Pedersen P

更新日期：2005-08-01 00:00:00

abstract：:A hazard model of fracture was developed using individual patient data (IPD) from the NHANES (2005-2008) database and summary-level data from an aggregate dataset (AD). The AD was built by performing a comprehensive and systematic literature search of clinical studies published from 1995 to 2015, recording fracture ra...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Eudy-Byrne RJ,Gillespie W,Riggs MM,Gastonguay MR

更新日期：2017-12-01 00:00:00

abstract：:We investigated the propagation of population pharmacokinetic information across clinical studies by applying Bayesian techniques. The aim was to summarize the population pharmacokinetic estimates of a study in appropriate statistical distributions in order to use them as Bayesian priors in consequent population pharm...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Dokoumetzidis A,Aarons L

更新日期：2005-08-01 00:00:00

abstract：:The purpose of this study was to develop a whole-body physiologically based pharmacokinetic (WB-PBPK) model for ciprofloxacin for ICU patients, based on only plasma concentration data. In a next step, tissue and organ concentration time profiles in patients were predicted using the developed model. The WB-PBPK model w...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Sadiq MW,Nielsen EI,Khachman D,Conil JM,Georges B,Houin G,Laffont CM,Karlsson MO,Friberg LE

更新日期：2017-04-01 00:00:00

abstract：:Minimal physiologically based pharmacokinetic (mPBPK) models provide a simple and sensible approach that incorporates physiological elements into pharmacokinetic (PK) analysis when only plasma data are available. With this modeling concept, a second-generation mPBPK model was further developed with specific accommodat...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Cao Y,Jusko WJ

更新日期：2014-12-01 00:00:00

abstract：:Several reviews on specific topics related to positron emission tomography (PET) ranging in complexity from introductory to highly technical have already been published. This introduction to the analysis of PET data was written as a simple guide of the different phases of analysis of a given PET dataset, from acquisit...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Tomasi G,Aboagye EO

更新日期：2013-08-01 00:00:00

abstract：:Guselkumab, a human IgG1 monoclonal antibody that blocks interleukin-23, has been evaluated in one Phase 2 and two Phase 3 trials in patients with moderate-to-severe psoriasis, in which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores. Throu...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Hu C,Yao Z,Chen Y,Randazzo B,Zhang L,Xu Z,Sharma A,Zhou H

更新日期：2018-08-01 00:00:00

abstract：:Regulatory authorities introduced procedures in the last decade for evaluating the bioequivalence (BE) for highly variable drugs. These approaches are similar in principle but differ in details. For example, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend differing regulatory c...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Endrenyi L,Tothfalusi L

更新日期：2019-04-01 00:00:00

abstract：:A modeling and simulation approach was used for quantitative comparison of a new generation HER2 antibody drug conjugate (ADC, PF-06804103) with trastuzumab-DM1 (T-DM1). To compare preclinical efficacy, the pharmacokinetic (PK)/pharmacodynamic (PD) relationship of PF-06804103 and T-DM1 was determined across a range of...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Betts A,Clark T,Jasper P,Tolsma J,van der Graaf PH,Graziani EI,Rosfjord E,Sung M,Ma D,Barletta F

更新日期：2020-10-01 00:00:00

abstract：:The study aimed to characterize the population pharmacokinetics of amodiaquine (AQ) and its major metabolite N-desethylamodiaquine (N-DEAQ), and to assess the correlation between exposure to N-DEAQ and treatment outcome. Blood samples from children in two studies in Zanzibar and one in Papua New Guinea were included i...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Hietala SF,Bhattarai A,Msellem M,Röshammar D,Ali AS,Strömberg J,Hombhanje FW,Kaneko A,Björkman A,Ashton M

更新日期：2007-10-01 00:00:00

abstract：:Bridging fundamental approaches to model optimization for pharmacometricians, systems pharmacologists and statisticians is a critical issue. These fields rely primarily on Maximum Likelihood and Extended Least Squares metrics with iterative estimation of parameters. Our research combines adaptive chaos synchronization...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Pillai N,Schwartz SL,Ho T,Dokoumetzidis A,Bies R,Freedman I

更新日期：2019-04-01 00:00:00

abstract：:Drugs can affect the cardiovascular (CV) system either as an intended treatment or as an unwanted side effect. In both cases, drug-induced cardiotoxicities such as arrhythmia and unfavourable hemodynamic effects can occur, and be described using mathematical models; such a model informed approach can provide valuable ...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Cheung SYA,Parkinson J,Wählby-Hamrén U,Dota CD,Kragh ÅM,Bergenholm L,Vik T,Collins T,Arfvidsson C,Pollard CE,Tomkinson HK,Hamrén B

更新日期：2018-06-01 00:00:00

abstract：:We explored the type I error rate (false positive rate) associated with exposure-response (ER) analyses for two compounds in a fixed-dose combination product through simulations. In the simulations, at least one compound was assumed to be inactive, whereas the active compound followed E(max) model at different concent...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Zhu H,Wang Y

更新日期：2011-12-01 00:00:00

abstract：:A number of experimental observations in the late 1960s, early 1970s could not be explained by the pharmacokinetic theory available at that time. For example rats receiving phenobarbital as an enzyme inducing agent exhibited increased elimination of phenylbutazone in vitro in liver microsomes and in vivo in whole anim...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Benet LZ

更新日期：2010-12-01 00:00:00

abstract：:This study developed an integrated model of severity scores of migraine headache and the incidence of nausea, photophobia, and phonophobia to predict the natural time course of migraine symptoms, which are likely to occur by a common disease progression mechanism. Data were acquired from two phase 3 clinical trials co...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Chae D,Park K

更新日期：2018-10-01 00:00:00

abstract：:There are situations in drug development where one may wish to reduce the dimensionality and complexity of whole body physiologically based pharmacokinetic models. A technique for formal reduction of such models, based on global sensitivity analysis, is suggested. Using this approach mean and variance of tissue(s) and...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Gueorguieva I,Nestorov IA,Rowland M

更新日期：2006-02-01 00:00:00

abstract：:Target-mediated drug disposition (TMDD) is frequently reported for therapeutic monoclonal antibodies and is linked to the high affinity and high specificity of antibody molecules for their target. Understanding TMDD of a monoclonal antibody should go beyond the empirical description of its non-linear PK since valuable...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Grimm HP

更新日期：2009-10-01 00:00:00

abstract：:The distributed delay model has been introduced that replaces the transit compartments in the classic model of chemotherapy-induced myelosuppression with a convolution integral. The maturation of granulocyte precursors in the bone marrow is described by the gamma probability density function with the shape parameter (...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Krzyzanski W,Hu S,Dunlavey M

更新日期：2018-04-01 00:00:00

abstract：:In this work a model for analyzing categorical data is presented; the differential odds model. Unlike the commonly used proportional odds model, this model does not assume that a covariate affects all categories equally on the log odds scale. The differential odds model was compared to the proportional odds model, by ...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Kjellsson MC,Zingmark PH,Jonsson EN,Karlsson MO

更新日期：2008-10-01 00:00:00

abstract：:To solve the problem of estimating an unknown input function to a linear time invariant system we propose an adaptive non-parametric method based on reversible jump Markov chain Monte Carlo (RJMCMC). We use piecewise polynomial functions (splines) to represent the input function. The RJMCMC algorithm allows the explor...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Kang D,Verotta D

更新日期：2007-06-01 00:00:00

abstract：:Disease progression of type 2 diabetes (T2D) has received considerable attention, but little is known about the disease development of T2D. The purposes of this study were to identify disease development variables (DDV) for development of T2D and to compare corresponding models for disease development. All subjects in...

journal_title：Journal of pharmacokinetics and pharmacodynamics

authors： Lin CW,Warram JH,Veng-Pedersen P

更新日期：2011-10-01 00:00:00