Abstract：
:Monoclonal antibodies (mAbs) represent a therapeutic strategy that has been increasingly used in different diseases. mAbs are highly specific for their targets leading to induce specific effector functions. Despite their therapeutic benefits, the presence of immunogenic reactions is of growing concern. The immunogenicity identified as anti-drug antibodies (ADA) production due to the continuous administration of mAbs may affect the pharmacokinetics (PK) and/or the pharmacodynamics (PD) of mAbs administered to patients. Therefore, the immunogenicity and its clinical impact have been studied by several authors using PK modeling approaches. In this review, the authors try to present all those models under a unique theoretical mechanism-based framework incorporating the main considerations related to ADA formation, and how ADA may affect the efficacy or toxicity profile of some therapeutic biomolecules.
journal_name
J Pharmacokinet Pharmacodynjournal_title
Journal of pharmacokinetics and pharmacodynamicsauthors
Gómez-Mantilla JD,Trocóniz IF,Parra-Guillén Z,Garrido MJdoi
10.1007/s10928-014-9367-zsubject
Has Abstractpub_date
2014-10-01 00:00:00pages
523-36issue
5eissn
1567-567Xissn
1573-8744journal_volume
41pub_type
杂志文章,评审abstract：:There have been no pharmacokinetic parameters and blood-brain equilibration rate constant (k e0) of propofol obtained in a single population of children, by which propofol can be administered using a target effect-site concentration controlled infusion. Thirty-nine, American Society of Anesthesiologists Physical Statu...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-015-9408-2
更新日期：2015-04-01 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
pub_type： 杂志文章
doi：10.1007/s10928-005-0004-8
更新日期：2006-02-01 00:00:00
abstract：:Effective long-term treatment of Type 2 Diabetes Mellitus (T2DM) implies modification of the disease processes that cause this progressive disorder. This paper proposes a mechanism-based approach to disease progression modeling of T2DM that aims to provide the ability to describe and quantify the effects of treatment ...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-006-9008-2
更新日期：2006-06-01 00:00:00
abstract：:During the course of therapeutic drug monitoring (TDM), doses are adjusted to attain a target concentration range and a correlation between clearance (CL) and dose is introduced. In population pharmacokinetic analyses of such TDM data, CL has frequently been modeled as a function of dose. This paper demonstrates by si...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-005-0083-6
更新日期：2005-12-01 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
pub_type： 杂志文章
doi：10.1007/s10928-016-9486-9
更新日期：2017-04-01 00:00:00
abstract：:Mixture modeling within the context of pharmacokinetic (PK)/pharmacodynamic (PD) mixed effects modeling is a useful tool to explore a population for the presence of two or more subpopulations, not explained by evaluated covariates. At present, statistical tests for the existence of mixed populations have not been deve...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1023/a:1025564409649
更新日期：2003-06-01 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
pub_type： 杂志文章
doi：10.1007/s10928-019-09629-4
更新日期：2019-04-01 00:00:00
abstract：:3-hydroxybenzo(a)pyrene (3-OHBaP) in urine has been proposed as a biomarker of occupational exposure to polycyclic aromatic hydrocarbons. However, to reconstruct exposure doses in workers from biomarker measurements, a thorough knowledge of the kinetics of the benzo(a)pyrene (BaP) and 3-OHBaP given different routes of...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-013-9338-9
更新日期：2013-12-01 00:00:00
abstract：:In the present pharmacokinetic/pharmacodynamic (PK/PD) evaluation, cortisol, total lymphocytes, and lymphocyte subpopulations were monitored following single oral doses of two oral formulations of 3 mg budesonide (BUD) (Dosage Forms A and B) in order to assess the differential effects that BUD may have on cortisol sup...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-006-9013-5
更新日期：2006-08-01 00:00:00
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
更新日期：2017-08-01 00:00:00
abstract：:HbA1c is the most commonly used biomarker for the adequacy of glycemic management in diabetic patients and a surrogate endpoint for anti-diabetic drug approval. In spite of an empirical description for the relationship between average glucose (AG) and HbA1c concentrations, obtained from the A1c-derived average glucose...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-012-9289-6
更新日期：2013-04-01 00:00:00
abstract：:The population approach to estimating mixed effects model parameters of interest in pharmacokinetic (PK) studies has been demonstrated to be an effective method in quantifying relevant population drug properties. The information available for each individual is usually sparse. As such, care should be taken to ensure t...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-005-2102-z
更新日期：2005-02-01 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
pub_type： 杂志文章
doi：10.1007/s10928-009-9126-8
更新日期：2009-08-01 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
pub_type： 杂志文章
doi：10.1007/s10928-008-9098-0
更新日期：2008-10-01 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
pub_type： 杂志文章,评审
doi：10.1007/s10928-013-9307-3
更新日期：2013-08-01 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
pub_type： 杂志文章
doi：10.1007/s10928-017-9551-z
更新日期：2017-12-01 00:00:00
abstract：:Assessment of the elimination of an oral test dose based on plasma concentration values requires correction for the effect of gastric release and absorption. Irregular uptake processes should be described 'model independently', which requires estimation of a large number of absorption parameters. To limit the associat...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-013-9299-z
更新日期：2013-04-01 00:00:00
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
更新日期：2001-08-01 00:00:00
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
更新日期：2001-10-01 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
pub_type： 杂志文章
doi：10.1007/s10928-011-9208-2
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
pub_type： 杂志文章
doi：10.1007/s10928-017-9556-7
更新日期：2018-04-01 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
pub_type： 杂志文章
doi：10.1007/s10928-020-09702-3
更新日期：2020-10-01 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
pub_type： 杂志文章
doi：10.1007/s10928-020-09732-x
更新日期：2021-01-03 00:00:00
abstract：:Structural identifiability is an often overlooked, but essential, prerequisite to the experiment design stage. The application of structural identifiability analysis to models of myelosuppression is used to demonstrate the importance of its considerations. It is shown that, under certain assumptions, these models are ...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章,meta分析
doi：10.1007/s10928-018-9569-x
更新日期：2018-02-01 00:00:00
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
更新日期：2019-02-01 00:00:00
abstract：:Pegylated liposomal formulations contain lipid conjugated to polyethylene glycol. The disposition of encapsulated drug is dictated by the composition of the liposome, thus altering the pharmacokinetic (PK) profile of the drug. Allometric scaling is based on a power-log relationship between body weight (W) and drug cle...
journal_title：Journal of pharmacokinetics and pharmacodynamics
pub_type： 杂志文章
doi：10.1007/s10928-011-9213-5
更新日期：2011-10-01 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
pub_type： 杂志文章,随机对照试验
doi：10.1007/s10928-018-9602-0
更新日期：2018-10-01 00:00:00
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
更新日期：2001-04-01 00:00:00
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
更新日期：2011-10-01 00:00:00
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
更新日期：2020-02-01 00:00:00
