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Category: 2016

2016

An analysis of patient-reported outcomes (PRO) in breast cancer patients through item-response theory (IRT) pharmacometric modeling

Posted on December 10, 2016 by Stefanie Hennig

Aims: Patient-reported outcomes (PRO) provide a valuable means to assess the subjective impact of a disease and treatment on patients’ symptoms, adverse effects...

2016

Optimization of trial design and dose selection based on the quantitative assessment of the efficacy of TAK-385, an investigational, oral GnRH antagonist, in patients with prostate cancer

Posted on December 10, 2016 by Stefanie Hennig

Aims: To select a dose for confirmatory trials using prospective simulations based on a PK/PD model of testosterone (T) suppression with the non-peptide gonadot...

2016

Bench-to-bedside translation of antibody drug conjugates (ADCs) using a multiscale mechanistic PK/PD model

Posted on December 10, 2016 by Stefanie Hennig

This presentation will highlight the importance of understanding and quantitatively integrating the preclinical PK of antibody-drug conjugates (ADCs) to enable ...

2016

Application of a multi-criteria decision analysis model in the dose selection of combination therapy for overactive bladder

Posted on December 10, 2016 by Stefanie Hennig

Aims: To support the selection of dose combination(s) of solifenacin and mirabegron for further development using a transparent and standardized approach, and t...

2016

Pharmacometrics, biostatistics and computational biology postgraduate training: how can we integrate courses?

Posted on December 10, 2016 by Stefanie Hennig

Aims: A career in pharmacometrics, biostatistics and computational biology attracts individuals who enjoy working with mathematical equations, data and writing ...

2016

Modeling tumor size and survival in patients with metastatic gastric cancer

Posted on December 10, 2016 by Stefanie Hennig

Aims: The aim of this study is to 1) model the temporal course of tumor size of stage IV gastric cancer patients enrolled into 1st line chemotherapy trials, and...

2016

Introduction to human challenge models for respiratory viruses and the application of quantitative pharmacology to enhance drug development

Posted on December 10, 2016 by Stefanie Hennig

Adult volunteer challenge models are commonly used in a number of infectious diseases, to demonstrate proof of concept for vaccines and large and small molecule...

2016

Pharmacometric modelling of antimalarial drugs in development

Posted on December 10, 2016 by Stefanie Hennig

Aims: Determination of minimum inhibitory concentration (MIC) of antimalarial drugs in the clinical setting may provide a valuable alternative to empirical appr...

2016

Developing next-generation malaria medicines to address drug resistance and increase the operational feasibility of malaria elimination efforts

Posted on December 10, 2016 by Stefanie Hennig

Aims: In 2015 the World Health Assembly endorsed the WHO Global Technical Strategy for Malaria 2016-20301, which aims to reduce global malaria incidence and mor...

2016

Recommended doses of Levobupivacaine for TAP Blocks: Development of a pharmacokinetic model and estimation of the risk of symptoms of local anesthetic systemic toxicity

Posted on December 10, 2016 by Stefanie Hennig

Aims: Tranversus Abdominal Plane (TAP) blocks are widely used for postoperative analgesia following abdominal surgery. In this block, the local anaesthetic (LA)...

2016

Assessment of pharmacometric and statistical analysis methods in dose-finding trial design: application in diabetes drug development

Posted on December 10, 2016 by Stefanie Hennig

Aims: To evaluate the performance of different pharmacometric and statistical methods of analysis when evaluating power of dose-finding trial designs for treatm...

2016

Why MIC is poison for the mind

Posted on December 10, 2016 by Stefanie Hennig

The cost of drug development has exploded in recent years and risen to a level that soon will no longer be affordable to society. One reason for the high cost o...

2016

A simple mechanistic pharmacometric model for HIV in children and adults

Posted on December 10, 2016 by Stefanie Hennig

Aims: Models for CD4 count and viral load have long been crucial in antiretroviral drug development [1], and have increasingly been used in long-term pharmacome...

2016

Population pharmacokinetics and pharmacodynamics of an oral glucagon receptor antagonist (LY2409021) and implications of patient dropout

Posted on December 6, 2016 by Stefanie Hennig

Aims: Study protocols for antidiabetic drugs often include withdrawing study participants due to elevated fasting plasma glucose (FPG) and glycosylated hemoglob...

2016

The importance of body size for bridging studies

Posted on December 6, 2016 by Stefanie Hennig

Clinical development standard in Japan has changed over the last decades along with ICH E5 and Japan guidelines (JP GLs; by MHLW, PMDA) that support use of non-...

2016

Modeling and simulation with evolving cancer therapies: combinations, cancer immunotherapy, and more

Posted on December 5, 2016 by Stefanie Hennig

Aims: Recent break-through and success in oncology including immuno-oncology and combination therapies has generated many excitement. With newer medicines being...

2016

Challenges in treating infectious disease – linking epidemiology with pharmacometrics

Posted on December 5, 2016 by Stefanie Hennig

Aims: In pharmacometric analyses, a goal is to quantify the impact of a therapeutic agent on a population of patients with a disease who will take the drug, wit...

2016

Application of a quantitative systems pharmacology (QSP) model to evaluate xCT inhibition as a target for central nervous system diseases.

Posted on November 9, 2016 by Mike Reed

Application of a quantitative systems pharmacology (QSP) model to evaluate xCT inhibition as a target for central nervous system diseases.   Aims: Neuronal exci...

2016

Big world challenges for pharmacometrics

Posted on November 8, 2016 by Stefanie Hennig

Aims From the outset, the aim of pharmacometrics has been to improve patient therapy through model based methods. The focus of these efforts have shifted over t...

2016

Placebo effect in overactive bladder clinical studies: longitudinal model-based meta-analysis of micturitions

Posted on November 3, 2016 by Chihiro Hasegawa

Aims: Existing evidence from clinical trial data suggests that a positive placebo effect occurs in overactive bladder (OAB) patients (1). Researchers also confi...

2016

Amikacin pharmacokinetics in Pediatric patients with burn injuries compared to those with oncology conditions

Posted on October 31, 2016 by Catherine MT Sherwin

Aims: Physiologic changes due to disease status can lead to highly variable pharmacokinetics (PK) of amikacin in children. Therefore, considerations should be g...

2016

A Framework for quantifying the influence of adherence and dose individualization

Posted on October 28, 2016 by Piyanan (Jill) Assawasuwannakit

Aims: The property of a drug that signifies the likelihood of therapeutic success to imperfect adherence is termed forgiveness. Recently forgiveness has been qu...

2016

Mechanism-based modelling to assess suppression of bacterial resistance by high intensity, short duration tobramycin exposure

Posted on October 28, 2016 by Vanessa Rees

  Aims: Infections involving hypermutable Pseudomonas aeruginosa (Pa) are highly problematic due to their enhanced resistance emergence. For aminoglycosides suc...

2016

Quantitative Review and Meta-models of Gastrointestinal Transit Times to Help Inform Mechanistic Oral Absorption Models

Posted on October 28, 2016 by Ahmad Y Abuhelwa

Aims: The in vivo performance of single-unit (“tablet/capsule”) and multiple-units (“pellets, multi-tablets”) dosage forms may sometime be markedly influenced b...

2016

Quantitative Review and Meta-models of Gastrointestinal pH to Help Inform Mechanistic Oral Absorption Models

Posted on October 28, 2016 by Ahmad Y Abuhelwa

Aims: The oral bioavailability of drugs is influenced by a many factors including the regional gastrointestinal (GI) pH. Small changes in the GI pH profile may ...

2016

The population pharmacokinetics of OZ439 in healthy volunteers and patients with falciparum and vivax malaria

Posted on October 28, 2016 by Piyanan (Jill) Assawasuwannakit

Aims: Artemisinin-based combination therapies are the recommended first-line treatment for falciparum malaria. Artemisinin derivatives, containing the peroxide ...

2016

Application of a multi-criteria decision analysis model in the dose selection of combination therapy for overactive bladder

Posted on October 19, 2016 by Mats O Magnusson

Aims: To support the selection of dose combination(s) of solifenacin and mirabegron for further development using a transparent and standardized approach, and t...

2016

Tofacitinib Pharmacokinetics in Moderate-to-Severe Crohn’s Disease Patients in Phase 2 Induction and Maintenance Studies

Posted on October 7, 2016 by Rujia Xie

Aims: Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for inflammatory bowel disease. The aims of this analysis were to...

2016

Population of Pharmacokinetics of Tanezumab in Pateints with Chronic Low Back Pain

Posted on October 6, 2016 by Rujia Xie

Aims: Tanezumab is a monoclonal lgG antibody targeted against nerve growth factor (NGF). It is currently under clinical development for the treatment of chronic...

2016

Examining the predictive performance of different equations to estimate glomerular filtration rate in paediatric oncology patients.

Posted on September 26, 2016 by Carolina Llanos Paez

Aims: The National Kidney Foundation guidelines recommend the use of equations to estimate glomerular filtration rate (GFR) in paediatrics and adults, some of w...

2016

Population pharmacokinetic model of gentamicin in paediatric oncology patients.

Posted on September 26, 2016 by Carolina Llanos Paez

Aims: To describe the population pharmacokinetics of gentamicin in paediatric febrile neutropenic patients and to identify covariates which explain pharmacokine...

2016

Application of continuous-time Marcov exposure-response model to sIGA. Nemolizumab case

Posted on September 20, 2016 by Tomohisa Saito

  Aims: It is usually more difficult to build a PK-PD model with discrete symptomatic disease endpoints than a PK-PD model with continuous biomarkers because a ...

2016

Evaluation of intraocular penetration of levofloxacin after administration drop solution by high performance liquid chromatography and comparison with ciprofloxacin

Posted on September 19, 2016 by Amir Heydari

Introduction: Levofloxacin is used to treat a wide variety of bacterial infections. Levofloxacin belongs to a class of drugs called quinolone antibiotics. It wo...

2016

Population pharmacokinetic model of pegylated interferon alfa-2a in healthy Korean male subjects

Posted on September 19, 2016 by YUN SEOB, JUNG

Aims: Pegylated interferon alfa-2a is an antiviral drug approved for the treatment of chronic hepatitic B and C. The addition of polyethylene glycol (pegylation...

2016

Would a certification process for models published on the DDMoRe repository serve the modelling community?

Posted on September 16, 2016 by Siv Jonsson

Aims: The Drug Disease Model Resources (DDMoRe, http://www.ddmore.eu/) consortium was created to improve the quality, efficiency and cost effectiveness of Model...

2016

An optimal sampling schedule for neonates, infants & children receiving cefazolin +/- vancomycin for cardiopulmonary bypass

Posted on September 16, 2016 by Jacqueline A Hannam

Background: Dosing of prophylactic antibiotics in children during cardiopulmonary bypass (CPB) remains poorly defined. Pharmacokinetic (PK) studies can be impro...

2016

Pseudomonas aeruginosa eradication therapy predicts the hazard of having Aspergillus Fumigatus positive culture in early life of children with CF

Posted on September 16, 2016 by Sabariah Noor Harun

Aims: To describe the hazard of having Aspergillus fumigatus positive cultures in young children (≤ 5 years of age) with cystic fibrosis (CF) and to investigate...

2016

What advanced methods and algorithms are promoted through DDMoRe?

Posted on September 15, 2016 by Andrew_Hooker

Aims: With the development of common language standards, an interoperability framework and a library of (certified) models the DDMoRe project makes the use of m...

2016

How can users benefit from the DDMoRe common language standard and interoperability framework?

Posted on September 15, 2016 by Phylinda LS Chan

Aims: DDMoRe is a consortium of European Federation of Pharmaceutical Industries and Associations (EFPIA), Academic and Small Medium Enterprise (SME) partners f...

2016

Evaluation of linezolid-induced thrombocytopenia based on hospital pharmacometrics

Posted on September 15, 2016 by Yasuhiro Tsuji

Aims: Thrombocytopenia and anemia are among the most important adverse effects of linezolid treatment. Linezolid-induced thrombocytopenia incidence varies consi...

2016

Evaluation of Covariate Effect Size based on Parameter Variability

Posted on August 29, 2016 by Takayuki Katsube

Aims: Parameter variability in a model can be described as an explained parameter variability with covariates (EPV) and unexplained parameter variability (UPV) ...

2016

A Quantitative Systems Pharmacology Model to Predict the Effects of Warfarin, Rivaroxaban and Enoxaparin on the Human Coagulation Network

Posted on August 28, 2016 by Mirjam Trame

Aims: Warfarin is the anticoagulant of choice for venous thromboembolism treatment. However, its suppression of the endogenous clot dissolution components PC an...

2016

Faster ADVAN-style analytical solutions for simulations from common pharmacokinetic models

Posted on August 25, 2016 by Ahmad Y Abuhelwa

Aims: ADVAN-style analytical solutions for 1, 2, 3 compartment linear pharmacokinetic models of intravenous bolus, infusion, and first-order absorption have bee...

2016

A population model for respiratory syncytial virus (RSV) kinetics using transit compartments based on human challenge data

Posted on August 25, 2016 by Julia Korell

Aims: Respiratory syncytial virus (RSV) causes acute respiratory tract infections, and is a major cause of hospital admissions and death in young children world...

2016

Model-Based Meta-Analysis on the Efficacy of Pharmacological Treatments for Idiopathic Pulmonary Fibrosis

Posted on August 23, 2016 by Phyllis Chan

Aims: Recently the FDA approved the first two drugs (pirfenidone and nintedanib) indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a therapeut...

2016

When statistics and pharmacometrics join forces for advanced quantitative drug development: A case study

Posted on August 22, 2016 by Emmanuel Zuber

Aims: The design of full development trials requires a number of features to be defined. Those include the population, treatment regimen, endpoint with clinical...

2016

What purpose is the DDMoRe library serving?

Posted on August 22, 2016 by Iñaki F. Trocóniz

DDMoRe, Drug Disease Model Resources, (http://www.ddmore.eu/) is an European project founded by the IMI and EFPIA, which aims to improve efficiency in the proce...

2016

Population Pharmacokinetics of Artesunate and Dihydroartemisinin in Patients with Sensitive and Resistant Malaria Infection

Posted on August 20, 2016 by Thanaporn Wattanakul

Aims: Artemisinin-resistant falciparum malaria is now prevalent in Southeast Asia. Understanding the pharmacokinetic and pharmacodynamic properties of artesunat...

2016

Pharmacokinetic Modeling and Simulation Analysis of LCB01-0371, a New Oxazolidinone Antibiotic Under Clinical Development

Posted on August 19, 2016 by Gwan Cheol Park

Aims: LCB01-0371 is a new oxazolidinone antibiotic with cyclic amidrazone under clinical development. It exerts its anti-bacterial activity by binding to bacter...

2016

A simulation study to evaluate treatment effect of tamoxifen by CYP2D6 genotypes compared with AIs

Posted on August 19, 2016 by Gwan Cheol Park

Aims: Tamoxifen is a prodrug, and active metabolites including endoxifen are known to exert its therapeutic effect of tamoxifen. Tamoxifen is converted to endox...

2016

Population Plasma and Urine Pharmacokinetics of Ivabradine and its Active Metabolite in Korean Healthy Volunteers

Posted on August 19, 2016 by Koh Ah Ra

Aims: Ivabradine, a selective inhibitor of the pacemaker current (If), is used for heart failure and coronary heart disease, and mainly metabolized to S18982 (1...

2016

Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of A Novel Donepezil Patch Formulation

Posted on August 19, 2016 by Koh Ah Ra

Aims: Donepezil is a well-known reversible noncompetitive acetylcholinesterase inhibitor for the symptomatic treatment of Alzheimer’s disease (AD). The purpose ...

2016

Physiologically Based Pharmacokinetic Models for Trastuzumab Using Serial Concentrations Meausred By Optical Imaging in Mouse

Posted on August 19, 2016 by Koh Ah Ra

Aims: Trastuzumab is a monoclonal antibody that is mainly used to treat breast cancer and exerts its therapeutic effect by inhibiting the HER2/neu receptor. The...

2016

Pharmacokinetic and Pharmacodynamic Analysis of GCC-4401C, a Novel Direct Factor Xa Inhibitor, in Healthy Volunteers

Posted on August 19, 2016 by Koh Ah Ra

Aims: GCC-4401C, an orally active direct factor Xa inhibitor which is similar to rivaroxaban, is currently under development for venous thromboembolic disease. ...

2016

Simulation Analysis to Explore the Optimal Combination of Pregabalin and Duloxetine

Posted on August 19, 2016 by Koh Ah Ra

Aims: Pregabalin, an anticonvulsant drug and duloxetine, a selective serotonin-norepinephrine reuptake inhibitor (SNRI) are used for pain relief. The purpose of...

2016

Internal Deterministic Identifiability

Posted on August 19, 2016 by Vijay Kumar Siripuram

Aims: Identifiability is an important component of model development. An identifiability analysis can provide the basis for understanding the limits of model st...

2016

Imputation methods to correct overestimated shape parameter of Weibull hazard function in time-to-event modeling

Posted on August 18, 2016 by Dong-Seok Yim

Aims: Hyper-acute, mass occurrence of events (e.g., at day 0~1) is not rare in biomedical data. If the event times are recorded on a daily basis in such situati...

2016

Mechanistic model for calcium treatment effect in calcium-parathyroid hormone homeostasis after thyroidectomy in Koreans.

Posted on August 18, 2016 by Mijeong Son

Aims: This study aims to develop a mechanism-based model of calcium treatment effect in calcium-parathyroid hormone (PTH) homeostasis after thyroidectomy in Kor...

2016

Development of a Biomarker-based Prediction Model of Disease Progression during Chemotherapy in Young Adolescents

Posted on August 18, 2016 by YOUNG A HEO

Aims: This study aims to develop a quantitative semi-mechanistic model to describe the disease progression of leukemia during chemotherapy using circulating bio...

2016

Advanced methods for dose finding during drug development: Summary of the EMA /EFPIA workshop on dose finding (London 4-5 December 2014)

Posted on August 18, 2016 by Flora Musuamba Tshinanu

Aims: The most commonly used methods for defining the dose rationale during early stage drug development i.e. pairwise comparison of different doses have shown ...

2016

How Pharmacometrics can improve the power of pharmacogenetic studies

Posted on August 17, 2016 by Julie Bertrand

Aims: Pharmacogenetics (PG) studies the relationship between genetic variation and drug response with the aim of providing more precision to the development of ...

2016

A viral kinetic model for severe human cytomegalovirus infections in immunocompromised paediatric patients

Posted on August 17, 2016 by Ben Margetts

Aims: To produce a viral kinetic (VK) model of Cytomegalovirus (CMV) that predicts changes in viral load within an individual as the infection responds to antiv...

2016

NextDose: a web-based collaborative tool for target concentration intervention

Posted on August 17, 2016 by samholford

Aims: The overarching aim of the NextDose project is to bring better dosing methods to the ward with target concentration intervention software. This includes t...

2016

Bayesian forecasting versus clinical practice for intravenous busulfan dose adjustment in paediatric stem cell transplantations

Posted on August 17, 2016 by Lachlan Paterson

Aims: Haematopoietic stem cell transplantation (HSCT) is a vital therapy that is used to cure high-risk or relapsed malignant and nonmalignant conditions. Busul...

2016

Population modelling of functional disability in early rheumatoid arthritis treated according to a treat-to-target strategy

Posted on August 16, 2016 by Jessica Wojciechowski

Aims: The treat-to-target approach in the management of rheumatoid arthritis (RA) involves frequent assessments of disease activity (measured by the 28-joint di...

2016

Comparison of non-compartmental analysis and non-linear mixed effects ability to determine bioequivalence in drugs with two-compartment kinetics

Posted on August 16, 2016 by Jim Henry Hughes

Aims: To develop a software tool with the ability to rapidly compare Non-Compartmental Analysis (NCA) and Non-Linear Mixed-Effect Modelling (NLMEM) methods in d...

2016

nlmixr: an open-source package for pharmacometric modelling in R

Posted on August 16, 2016 by Rik Schoemaker

Aims: nlmixr is an open-source R package under development that builds on both RxODE1, an R package for simulation of nonlinear mixed effect models using ordina...

2016

Translation between two models; Application with integrated glucose homeostasis models

Posted on August 15, 2016 by Moustafa Ibrahim

Aims: Both the Integrated Glucose Insulin model (IGI) and the Integrated Minimal Model (IMM) have been proposed to characterize simultaneously glucose-insulin r...

2016

Population Pharmacokinetic Analysis of Levetiracetam in Adult Malaysian Patients with Epilepsy

Posted on August 15, 2016 by Yoke-Lin Lo

Aims: To determine the pharmacokinetic parameters of levetiracetam (LEV), a third-generation antiepileptic drug, and its metabolite, etiracetam carboxylic acid ...

2016

Road to individualising tacrolimus therapy in solid organ transplant recipients

Posted on August 14, 2016 by Christine Staatz

Road to individualising tacrolimus therapy in solid organ transplant recipients Christine E. Staatz1 1University of Queensland, School of Pharmacy, Brisbane, QL...

2016

Pharmacometric modelling of antimalarial drugs in development: from challenge to clinics

Posted on August 12, 2016 by Nathalie Gobeau

Aims: guide the dose finding in clinical studies based on the Induced Blood Stage Malaria (IBSM) challenge studies and population pharmacokinetic-pharmacodynami...

2016

Prediction of fat free mass in children

Posted on August 12, 2016 by Hesham Al-Sallami

Aims: Fat free mass (FFM) describes the non-fat component of the body. It has been advocated as an appropriate size descriptor to scale drug clearance (CL) and ...

2016

Understanding the influence of vitamin K on warfarin dosing requirements

Posted on August 12, 2016 by Qing Xi Ooi

Aims: Warfarin acts by inhibiting the reduction of vitamin K (VK) to its active form, thereby decreasing the production of VK-dependent coagulation factors. The...

2016

Regulatory endorsed of M&S platforms: The case of Alzheimer Disease CTS

Posted on August 12, 2016 by Klaus Romero

Background: Understanding disease progression, drug and placebo effects, as well as drop-outs in Alzheimer’s disease (AD) studies is critical in order to ...

2016

Using a PK/PD modeling approach to optimize the dosing regimen of secukinumab for the treatment of moderate to severe plaque psoriasis

Posted on August 11, 2016 by Mick Looby

  Aims: Optimize the dosing regimen for an antibody-based therapy of psoriasis using Phase 1 and 2 data.   Methods: Optimizing dosing regimens is challenging in...

2016

Dose selection for rifabutin in combination with HIV-protease inhibitors

Posted on August 11, 2016 by Stefanie Hennig

  Aims: Extensive but fragmented data from existing studies were used to describe the drug-drug interaction between rifabutin and HIV-protease inhibitors, and p...

2016

Understanding Identifiability of random effects in mixed effects models

Posted on August 11, 2016 by Leon Aarons

Aims: We discuss the question of model identifiability within the context of nonlinear mixed effects models and application to pharmacokinetic models. Methods: ...

2016

Quantitative model diagrams (QMD): a new perspective in model evaluation

Posted on August 11, 2016 by Benjamin Guiastrennec

Aims: To facilitate model communication and evaluation through intuitive visual representation of their structure, parameter values and uncertainty. Methods: An...

2016

A pilot study to investigate the relationship between doxorubicin and doxorubicinol pharmacokinetics and cardiotoxicity in children and adolescents with cancer

Posted on August 11, 2016 by Stefanie Hennig

Aims: The primary aim of this pilot study was to assess the relationship between doxorubicin (dox) and doxorubicinol (doxinol) pharmacokinetics (PK) and markers...

2016

Using normal fat mass to account for body size and composition

Posted on August 8, 2016 by Nick Holford

Aims:    Allometry is the study of how body size is related to body function. In clinical medicine, size related differences in biological functions such as hea...

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