When is a metric not a metric? Remarks on direct curve comparison in bioequivalence studies.

Abstract:

:The majority of measures proposed to date for direct curve comparison in bioequivalence studies were investigated. These measures have often been called metrics, but in most cases this was incorrect in the mathematical sense. It was demonstrated, with a set of counter-examples, that the axioms of a metric are fulfilled only for the integral p-metric and some of its transforms. The Rescigno index and two other measures devised by Polli and McLean are the semi-metrics, lacking the triangle inequality, while others also lack symmetry. The use of the p-metric is therefore recommended, and statistical analysis is suggested as a point at which the scaling of differences might be carried out.

authors

Jawień W

doi

10.1007/s10928-009-9121-0

subject

Has Abstract

pub_date

2009-06-01 00:00:00

pages

261-79

issue

3

eissn

1567-567X

issn

1573-8744

journal_volume

36

pub_type

杂志文章
  • Linking interleukin-6 receptor blockade with tocilizumab and its hematological effects using a modeling approach.

    abstract::Tocilizumab is a recombinant humanized antihuman interleukin-6 receptor monoclonal antibody, which inhibits binding of IL-6 to its soluble (sIL-6R) and membrane-expressed (mIL-6R) receptors. The work investigated whether the observed decline in peripheral neutrophil and platelet counts after tocilizumab administration...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s10928-011-9227-z

    authors: Gibiansky L,Frey N

    更新日期:2012-02-01 00:00:00

  • Is mixed effects modeling or naïve pooled data analysis preferred for the interpretation of single sample per subject toxicokinetic data?

    abstract::The purpose of this study was to evaluate whether mixed effects modeling (MEM) performs better than either noncompartmental or compartmental naïve pooled data (NPD) analysis for the interpretation of single sample per subject pharmacokinetic (PK) data. Using PK parameters determined during a toxicokinetic study in rat...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1023/a:1011507100493

    authors: Hing JP,Woolfrey SG,Greenslade D,Wright PM

    更新日期:2001-04-01 00:00:00

  • Operating characteristics of stepwise covariate selection in pharmacometric modeling.

    abstract::Stepwise covariate modeling (SCM) is a widely used tool in pharmacometric analyses to identify covariates that explain between-subject variability (BSV) in exposure and exposure-response relationships. However, this approach has several potential weaknesses, including over-estimated covariate effect and incorrect sele...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-019-09635-6

    authors: Ahamadi M,Largajolli A,Diderichsen PM,de Greef R,Kerbusch T,Witjes H,Chawla A,Davis CB,Gheyas F

    更新日期:2019-06-01 00:00:00

  • Impact of aminophylline on the pharmacodynamics of propofol in beagle dogs.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-014-9377-x

    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

  • Evaluation of bootstrap methods for estimating uncertainty of parameters in nonlinear mixed-effects models: a simulation study in population pharmacokinetics.

    abstract::Bootstrap methods are used in many disciplines to estimate the uncertainty of parameters, including multi-level or linear mixed-effects models. Residual-based bootstrap methods which resample both random effects and residuals are an alternative approach to case bootstrap, which resamples the individuals. Most PKPD app...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-013-9343-z

    authors: Thai HT,Mentré F,Holford NH,Veyrat-Follet C,Comets E

    更新日期:2014-02-01 00:00:00

  • Modeling T cell responses to antigenic challenge.

    abstract::T cell responses are a crucial part of the adaptive immune system in the fight against infections. This article discusses the use of mathematical models for understanding the dynamics of cytotoxic T lymphocyte (CTL) responses against viral infections. Complementing experimental research, mathematical models have been ...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章,评审

    doi:10.1007/s10928-014-9387-8

    authors: Wodarz D

    更新日期:2014-10-01 00:00:00

  • Bayesian approach to investigate a two-state mixed model of COPD exacerbations.

    abstract::Chronic obstructive pulmonary disease (COPD) is a chronic obstructive disease of the airways. An exacerbation of COPD is defined as shortness of breath, cough, and sputum production. New therapies for COPD exacerbations are examined in clinical trials frequently based on the number of exacerbations that implies long-t...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-019-09643-6

    authors: Largajolli A,Beerahee M,Yang S

    更新日期:2019-08-01 00:00:00

  • A tutorial on model informed approaches to cardiovascular safety with focus on cardiac repolarisation.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-018-9589-6

    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

  • A whole-body physiologically based pharmacokinetic (WB-PBPK) model of ciprofloxacin: a step towards predicting bacterial killing at sites of infection.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-016-9486-9

    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

  • Evaluation of false positive rate based on exposure-response analyses for two compounds in fixed-dose combination products.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-011-9214-4

    authors: Zhu H,Wang Y

    更新日期:2011-12-01 00:00:00

  • Benchmarking renin suppression and blood pressure reduction of direct renin inhibitor imarikiren through quantitative systems pharmacology modeling.

    abstract::Multiple classes of antihypertensive drugs inhibit components of the renin-angiotensin-aldosterone system (RAAS). The primary physiological effector of the RAAS is angiotensin II (AngII) bound to the AT1 receptor (AT1-bound AngII). There is a strong non-linear feedback from AT1-bound AngII on renin secretion. Since AT...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-018-9612-y

    authors: Gebremichael Y,Lahu G,Vakilynejad M,Hallow KM

    更新日期:2019-02-01 00:00:00

  • Potential errors in the volume of distribution estimation of therapeutic proteins composed of differently cleared components.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-011-9209-1

    authors: Richter WF,Grimm HP,Theil FP

    更新日期:2011-10-01 00:00:00

  • Mechanism-based pharmacokinetic-pharmacodynamic modeling of antimicrobial drug effects.

    abstract::Mathematical modeling of drug effects maximizes the information gained from an experiment, provides further insight into the mechanisms of drug effects, and allows for simulations in order to design studies or even to derive clinical treatment strategies. We reviewed modeling of antimicrobial drug effects and show tha...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章,评审

    doi:10.1007/s10928-007-9069-x

    authors: Czock D,Keller F

    更新日期:2007-12-01 00:00:00

  • Comparison of proportional and differential odds models for mixed-effects analysis of categorical data.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-008-9098-0

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

    更新日期:2008-10-01 00:00:00

  • Bioequivalence testing by statistical shape analysis.

    abstract::Bioequivalence testing has been traditionally centered in summary variables such as AUC, C (max) and t (max) which filter out the intrinsic information conveyed by discrete sequential concentration-time observations. Comparing entire concentration-time profiles between test and reference formulations for bioequivalenc...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-007-9055-3

    authors: Pereira LM

    更新日期:2007-08-01 00:00:00

  • Propagation of population pharmacokinetic information using a Bayesian approach: comparison with meta-analysis.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-005-0048-9

    authors: Dokoumetzidis A,Aarons L

    更新日期:2005-08-01 00:00:00

  • Mathematical description of drug-target interactions: application to biologics that bind to targets with two binding sites.

    abstract::The emerging discipline of mathematical pharmacology occupies the space between advanced pharmacometrics and systems biology. A characteristic feature of the approach is application of advance mathematical methods to study the behavior of biological systems as described by mathematical (most often differential) equati...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-017-9546-9

    authors: Gibiansky L,Gibiansky E

    更新日期:2018-02-01 00:00:00

  • Modeling cancer-immune responses to therapy.

    abstract::Cancer therapies that harness the actions of the immune response, such as targeted monoclonal antibody treatments and therapeutic vaccines, are relatively new and promising in the landscape of cancer treatment options. Mathematical modeling and simulation of immune-modifying therapies can help to offset the costs of d...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-014-9386-9

    authors: dePillis LG,Eladdadi A,Radunskaya AE

    更新日期:2014-10-01 00:00:00

  • Optimization of clinical dosing schedule to manage neutropenia: learnings from semi-mechanistic modeling simulation approach.

    abstract::Neutropenia is a common side-effect of oncology drugs. We aimed to study the impact of exposure and dosing schedule on neutropenia to guide selection of dosing schedules that minimize neutropenia potential while maintaining the desired minimum concentration (Cmin) required for target engagement. Dose, frequency and PK...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-019-09667-y

    authors: Guo Y,Haddish-Berhane N,Xie H,Ouellet D

    更新日期:2020-02-01 00:00:00

  • Covariate-based dose individualization of the cytotoxic drug indisulam to reduce the risk of severe myelosuppression.

    abstract:AIM:Chemotherapy with indisulam causes myelosuppression. This study aimed to evaluate the influence of patient-related covariates on pharmacokinetics and pharmacodynamics, to identify patients at risk for severe myelosuppression and to develop a dosing algorithm for treatment optimization. METHODS:Pharmacokinetic and ...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-009-9111-2

    authors: Zandvliet AS,Schellens JH,Copalu W,Beijnen JH,Huitema AD

    更新日期:2009-02-01 00:00:00

  • A non-linear mixed effect dynamic model incorporating prior exposure and adherence to treatment to describe long-term therapy outcome in HIV-patients.

    abstract::Long term therapy with antiretroviral agents in HIV-infected patients often result in failure to suppress the virus load. Imperfect adherence to prescribed antiviral drugs is an important factor explaining the resurgence of virus. A better understanding of the factors responsible for the virological failure is importa...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-006-9022-4

    authors: Labbé L,Verotta D

    更新日期:2006-08-01 00:00:00

  • Gaining insights into the consequences of target-mediated drug disposition of monoclonal antibodies using quasi-steady-state approximations.

    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

    pub_type: 杂志文章,评审

    doi:10.1007/s10928-009-9129-5

    authors: Grimm HP

    更新日期:2009-10-01 00:00:00

  • Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers.

    abstract::The pharmacokinetic-pharmacodynamic (PK-PD) relationship of the granulopoietic effects of Filgrastim in healthy volunteers was characterized via a population approach. Healthy male volunteers were enrolled into a four-way crossover clinical trial. Subjects received four single doses of Filgrastim (375 and 750 microgra...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1023/a:1011534529622

    authors: Wang B,Ludden TM,Cheung EN,Schwab GG,Roskos LK

    更新日期:2001-08-01 00:00:00

  • A model of fracture risk used to examine the link between bone mineral density and the impact of different therapeutic mechanisms on fracture outcomes in patients with osteoporosis.

    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

    pub_type: 杂志文章

    doi:10.1007/s10928-017-9551-z

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

    更新日期:2017-12-01 00:00:00

  • The effect of using a robust optimality criterion in model based adaptive optimization.

    abstract::Optimizing designs using robust (global) optimality criteria has been shown to be a more flexible approach compared to using local optimality criteria. Additionally, model based adaptive optimal design (MBAOD) may be less sensitive to misspecification in the prior information available at the design stage. In this wor...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-017-9521-5

    authors: Strömberg EA,Hooker AC

    更新日期:2017-08-01 00:00:00

  • A stochastic model describes the heterogeneous pharmacokinetics of cyclosporin.

    abstract::The pharmacokinetics of cyclosporin (CsA) are unusual because of several heterogeneous features which include the presence of more than one conformer, considerable accumulation in erythrocytes and lipoproteins, extensive plasma protein binding, distribution into deep tissues, biliary secretion and hepatic clearance in...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1023/a:1012295014352

    authors: Claret L,Iliadis A,Macheras P

    更新日期:2001-10-01 00:00:00

  • Role of expression of prostaglandin synthases 1 and 2 and leukotriene C4 synthase in aspirin-intolerant asthma: a theoretical study.

    abstract::Altered expressions of the key enzymes in arachidonic acid (AA) metabolism, prostaglandin synthase 1 and 2 and cysteinyl leukotriene C(4) synthase, are of importance in understanding aspirin-induced asthma. We propose a mathematical model of AA metabolism and its interaction with non-steroidal anti-inflammatory drugs ...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-011-9192-6

    authors: Dobovišek A,Fajmut A,Brumen M

    更新日期:2011-04-01 00:00:00

  • Analysis of PK/PD risk factors for development of type 2 diabetes in high risk population using Bayesian analysis of glucose-insulin kinetics.

    abstract::This study was designed to investigate the pharmacokinetics/pharmacodynamics (PK/PD) risk factors preceding the onset of type 2 diabetes using a population-based Bayesian nonlinear hierarchical model to describe the glucose-insulin kinetics. One hundred fifty-two healthy subjects with a family history of type 2 diabet...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-009-9130-z

    authors: Lin CW,Veng-Pedersen P

    更新日期:2009-10-01 00:00:00

  • Physiologically based synthetic models of hepatic disposition.

    abstract::Current physiologically based pharmacokinetic (PBPK) models are inductive. We present an additional, different approach that is based on the synthetic rather than the inductive approach to modeling and simulation. It relies on object-oriented programming. A model of the referent system in its experimental context is s...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1007/s10928-006-9031-3

    authors: Hunt CA,Ropella GE,Yan L,Hung DY,Roberts MS

    更新日期:2006-12-01 00:00:00

  • A compartmental model of hepatic disposition kinetics: 1. Model development and application to linear kinetics.

    abstract::The conventional convection-dispersion model is widely used to interrelate hepatic availability (F) and clearance (Cl) with the morphology and physiology of the liver and to predict effects such as changes in liver bloodflow on F and Cl. The extension of this model to include nonlinear kinetics and zonal heterogeneity...

    journal_title:Journal of pharmacokinetics and pharmacodynamics

    pub_type: 杂志文章

    doi:10.1023/a:1019703607647

    authors: Anissimov YG,Roberts MS

    更新日期:2002-04-01 00:00:00